DIABETIC FOOT ULCERS

DIABETIC FOOT ULCERS








Diabetic Foot Ulcers

Foot ulcers are a major complication, occurring in approximately 15% of people with diabetes mellitus, and are a preceding factor in approximately 85% of lower limb amputations. Poor diabetes control may result in peripheral neuropathy and vascular disease. Peripheral neuropathy raises the likelihood of both trauma to the foot and inability to detect abnormal pressures that may predispose patients to develop foot ulcers.

Updated 2008

Diabetic Foot Ulcers

Foot ulcers are a major complication, occurring in approximately 15% of people with diabetes mellitus, and are a preceding factor in approximately 85% of lower limb amputations. Poor diabetes control may result in peripheral neuropathy and vascular disease. Peripheral neuropathy raises the likelihood of both trauma to the foot and inability to detect abnormal pressures that may predispose patients to develop foot ulcers.

Clinicians have the opportunity to positively influence client outcomes and quality of life by using effective strategies to try to prevent foot ulceration. Up to 85% of diabetic foot ulcers can be prevented. If ulceration has occurred, clinicians will improve outcomes by identifying and treating the cause, addressing patient-centered concerns, providing local wound care, and ensuring organizational support of evidence-based care through interdisciplinary intervention.

A systematic literature search for clinical practice guidelines on foot ulcer prevention and treatment was done using the Medline, CINAHL, and Embase databases and 46 guideline clearinghouses. A librarian was involved in helping identify the appropriate keywords and search strategies to ensure that all guidelines on the topic were found.

Thirty-two (32) foot ulcer prevention and treatment clinical practice guidelines were found in the English literature from 2002 until May 2007. Twenty-two (22) of these published articles were excluded because they were: recommendations or practical guide (3), an algorithm or protocol (4), individual studies (5), a summary of guidelines (2), an educational program (1), a consensus or position statement (3), unavailable (3), proceedings of a conference (1).

Of the identified papers, ten guidelines were appraised by a minimum of three reviewers using the AGREE instrument (http://www.agreecollaboration.org/instrument/). The AGREE instrument has six domains: scope and purpose, stakeholder involvement, rigour of development, clarity and presentation, applicability, and editorial independence. It is not recommended that the scores obtained for the domains be aggregated. Instead the guidelines that received the highest scores for most of the domains and particularly for rigour of development were ranked highest and their recommendations will be reported throughout this diabetic foot ulcer stream.

The most highly ranked guidelines were two that were developed by the Registered Nurses Association of Ontario (RNAO), one on assessment and management of foot ulcers for people with diabetes (2005), the other on reducing foot complications for people with diabetes (2004); one by the National Institute for Clinical Excellence (NICE) on the prevention and management of foot problems in people with type 2 diabetes (2004); one by Lipsky et al on the diagnosis and treatment of diabetic foot infections (2004).

Identify and Treat the Cause Level of Evidence
1 Take a careful history (general history, diabetic control and complications). 1b
2 Conduct a foot inspection and examine for decreased sensation. Correct (if possible) risk factors for ulcer formation/amputation: – Vascular supply – Infection – Pressure (including bony deformity)) through pressure redistribution using accommodative footwear. Remember the mnemonic VIP Also, correct (if possible) co-factors that may affect healing. 1a
Address Patient-Centered Concerns Level of Evidence
3 Provide individualized education to enhance Glycemic control, Adherence to treatment, Plantar pressure redistribution/daily foot inspection. (GAP) 1a
Provide Local Wound Care Level of Evidence
4 Assess and document depth of trauma and extent of healing, with ulcer duration, location, size, and depth (probe to bone). 2a
5 Optimize wound healing environment through Debridement, Infection (bacterial burden control) and Moisture balance. (DIM) 1a
6 Consider the edge effect. For stalled wounds, consider the use of biological agents and adjunctive therapies (edge effect). DIM/E 1a
Provide Organizational Support Level of Evidence
7 Establish and empower an interprofessional team to work with Persons With Diabetes (PWD). 4

High Ranking Guidelines

1 Quality Indicator Type: CPG (Clinical Practice Guideline)
Registered Nurses Association of Ontario (RNAO). Assessment and management of foot ulcers for people with diabetes. Toronto (ON): Registered Nurses Association of Ontario (RNAO); 2005 Mar. 112 p.
For clinicians or administrators who want to know the details, this comprehensive guideline provides the most recent systematically searched evidence and consensus reporting on the assessment and management of foot ulcers.
2 Quality Indicator Type: CPG (Clinical Practice Guideline)
Registered Nurses Association of Ontario (RNAO). Reducing foot complications for people with diabetes. Toronto (ON): Registered Nurses Association of Ontario (RNAO); 2004 Mar. 80 p.
This comprehensive guideline provides clinicians with the most recent systematically searched evidence and consensus reporting about the reduction of foot complications in prople with diabetes.
3 Quality Indicator Type: CPG (Clinical Practice Guideline)
National Collaborating Centre for Primary Care. Clinical guidelines for type 2 diabetes. Prevention and management of foot problems. London (UK): National Institute for Clinical Excellence (NICE); 2004 Jun. 104 p.
This comprehensive guideline provides clinicians with recent systematically searched evidence and consensus reporting about the prevention and management of diabetic foot problems. Its recommendations are made in additional areas to those addressed by the RNAO guidelines.
4 Quality Indicator Type: Concensus Statement
Lipsky BA, Berendt AR, Deery HG, Embil JM, Joseph WS, Karchmer AW, Lefrock JL, Lew DP, Mader JT, Norden C, Tan JS. Diagnosis and treatment of diabetic foot infections. Clin Infect Dis 2004 Oct 1;39(7):885-910.
This comprehensive systematically searched evidence and consensus guideline provides found that specifically addressed the diagnosis and treatment of diabetic foot infections.

Assessment

The diabetic foot syndrome comprises neuropathy, deformity and vascular insufficiency, which eventually lead to complications of ulceration and amputation. These complications affect approximately 15% of diabetic patients and are associated with increased morbidity and mortality and decreased quality of life. Foot ulcers are the leading cause of hospitalization in patients with diabetes and precede amputation in 85% of cases. Comprehensive assessment of the diabetic foot is necessary to institute both preventive and treatment strategies and is required for all patients presenting with ulceration.

A detailed history, complete physical examination and appropriate investigations can determine general health and identify systemic risk factors for ulcer development and factors that influence healing. These include smoking, nutritional deficiency, recurrent trauma, diabetic control, medications that can interfere with healing, malignancy, autoimmune disorders, obesity, renal failure, jaundice, and vascular insufficiency. Psychosocial status, cognitive function and functional status also affect ulcer healing. Local factors that can affect wound healing include loss of protective sensation, decreased blood supply, mechanical stress, edema, hematoma and infection. Other relevant systemic and local factors may also be present.

Ulcer staging or grading is crucial to planning treatment, monitoring effectiveness, predicting outcomes and facilitating communication among the clinical team caring for the patient. The ulcer should be assessed and categorized, using an accepted system, such as the Wagner system or the University of Texas classification.

The Wagner Classification grades diabetic ulcers as follows: 1: Superficial ulcer with partial- or full-thickness skin loss 2: Probing to tendon or capsule with soft-tissue infection 3: Deep ulcer with osteomyelitis 4: Ulcer with forefoot gangrene 5: Ulcer with gangrene involving entire foot

The University of Texas Diabetic Wound Classification System uses a matrix to divide ulcers into stages A to D and grades 1 to 3. Stages: A: Clean wound B: Nonischemic infected wound C: Ischemic noninfected wound D: Ischemic infected wound

Grades 1: Superficial wound 2: Wound penetrating to tendon or capsule 3: Wound penetrating bone or joint.

Increasing stage is associated with increased healing time and risk of amputation. The increased detail in the University of Texas system allows improved prediction of outcome.

Identify and Treat the Cause Level of Evidence
1 Perform a complete history, physical examination and appropriate laboratory investigations to identify systemic factors affecting ulcer development and healing. Not Assessed
2 Conduct a detailed examination of the foot to identify local factors affecting ulcer healing. Not Assessed
3 Conduct a foot inspection and examine for decreased sensation. Correct (if possible) risk factors for ulcer formation/amputation: ♦ Vascular supply ♦ Infection ♦ Pressure (including bony deformity) Not Assessed
Address patient-centered Concerns Level of Evidence
4 Provide individualized education to enhance Glycemic control, Adherence to treatment, Plantar pressure redistribution/daily foot inspection. (GAP) Not Assessed
Provide Local Wound Care
n/a
Provide Organizational Support Level of Evidence
5 Include ulcer staging in protocols relating to ulcer assessment and management to facilitate treatment planning, monitoring of effectiveness, and communication among the team caring for the patient. Not Assessed
6 Diabetic foot care clinics should review ulcer classification systems and adopt one that best meets the needs of their patient population. Not Assessed
7 Establish and empower an interprofessional team to work with Persons With Diabetes (PWD). Not Assessed

Essential Publications

1 University of Texas Diabetic Wound Classification System Quality Indicator Type:
Lavery LA, Armstrong DG, Harkless LB. Classification of diabetic foot wounds. J Foot Ankle Surg 1996;35:528-531
This well-known classification system for diabetic foot infections developed to guide future surgical treatment protocols, algorithms. The classification system grades depth, ischaemia and infection.
2 University of Texas Diabetic Wound Classification System – validation Quality Indicator Type: RCT
Armstrong DG, Lavery LA, Harkless LB. Validation of a diabetic wound classification system. Diabetes care 1998;21(5):855-858.
Validation of the grading system based on retrospective analysis of medical records of 360 diabetic patients in multidisciplinary tertiary care diabetic foot clinic, illustrating that outcomes deteriorate with increasing grade and stage of wounds
3 Wagner Grading System for the Dysvascular Foot Quality Indicator Type: RCT
Wagner FW. The Dysvascular Foot: A system for diagnosis and treatment. Foot & Ankle 1981;2(2):64-122.
This is the well-known Wagner foot grading system, devised by Dr. Wagner, through observing progression of diabetic foot lesions. The classification system was developed to guide future surgical treatment protocols. Grading system: Grade 0 – no open lesion, Grade 1 – superficial ulcer, Grade 2 – deep ulcer, Grade 3 – absess osteitis, Grade 4 – gangrene forefoot, Grade 5 – gangrene entire foot.
4 Wagner Classification – validation Quality Indicator Type: Retrospective Analysis
Calhoun JH, Cantrell J, Cobos J, Lacy J, Valdex RR, Hokanson J, Mader JT. Treatment of Diabetic Foot Infections: Wagner Classification, Therapy, and Outcome. Foot & Ankle 1988;9(3):101-106.
In retrospective analysis, use of the Wagner classification system and therapy algorithms was shown to be a reasonable approach.
5 Clinical Diagnosis of Osteomyelitis Quality Indicator Type: Systematic review
Butalia S, Palda VA, Sargeant RJ, Detsky AS, Mourad O. Does this patient with diabetes have osteomyelitis of the lower extremity? JAMA 2008;299(7):806-813.
This systematic review was conducted to evaluate the diagnostic accuracy of historical features, physical examination, laboratory tests, radiographic tests and magnetic resonance imagining (MRI) compared with bone biopsy (the reference standard) in patients with diabetes. Each of the following increase the odds of osteomyelitis: ulcer size greater than 2 cm2, positive “probe-to-bone” test, erythrocyte sedimentation rate of more than 70 mm/h, abnormal radiograph, and positive MRI. A normal MRI result makes osteomyelitis very unlikely. The diagnostic usefulness of combining these test results was not determined.
6 Clinical Diagnosis of Osteomyelitis – validation of probe-to-bone test Quality Indicator Type: Longitudinal study (1 group)
Lavery LA, . Armstrong DG, Peters EJG, Lipsky BA. Probe-to-Bone Test for Diagnosing Diabetic Foot Osteomyelitis: Reliable or relic? Diabetes Care 2007;30(2):270-4.
This is a recent evaluation of the probe to bone (PTB) test in relation to bone biopsy in 247 patients with diabetes attending a foot clinic. Although it appears that efforts were made to ensure that the decision to perform the ‘gold standard’ test, bone biopsy, was made independent of the PTB test, this is a potential source of bias. The incidence of infections was 12%. Using all wounds, the positive predictive value of the PTB test was found to be low (0.57), but the negative predictive value was high (0.98) suggesting that a negative PTB test is better at ruling out infection than detecting it in this particular population. Replication of this work in this and other populations is important.
7 Clinical Diagnosis of Osteomyelitis – description of probe-to-bone test Quality Indicator Type: Scale Description
Grayson ML, Gibbons GW, Balogh K, Levin E, Karchmer AW. Probing to bone in infected pedal ulcers. A clinical sign of underlying osteomyelitis in diabetic patients. JAMA 1995;273(9):721-723.
In this article the probe to bone test for detecting osteomyelitis is described. Its validity was ascertained in relation to histological findings. The test had sensitivity of 66% and specificity of 85%, with positive predictive value of 89% in hospitalized patients with limb-threatening foot infections. The probe to bone test is often used clinically to diagnose osteomyelitis.
8 Assessment of the diabetic foot Quality Indicator Type: Longitudinal study (1 group)
Abbott CA, Carrington AL, Ashe H, Bath S, Every LC, Griffiths J, Hann AW, Hussein A, Jackson N, Johnson KE, Ryder CH, Torkington R, Van Ross ER, Whalley AM, Widdows P, Williamson S, Boulton AJ; North-West Diabetes Foot Care Study. The North-West Diabetes Foot Care Study: incidence of, and risk factors for, new diabetic foot ulceration in a community-based patient cohort. Diabet Med. 2002 May;19(5):377-84.
This study examines the incidence of, and risk factors for, diabetic foot ulceration. The results demonstrated that over 2% of diabetic patients develop new foot ulcers, and that neuropathy disability score, 10 g monofilament and palpation of foot pulses should be used as screening tools.

Background: Context

This summary provides background information to assist in reviewing topics within the category of diabetic foot ulcers.

Diabetes, a complex metabolic disorder affecting approximately 1.5 million Canadians, is increasing in prevalence, and the age of onset appears to be decreasing, with cases found in children in grade school. Among the aboriginal population, the prevalence of diabetes is at least three times that of the population as a whole. With longevity of the population increasing, the prevalence of complications will continue to increase.

Abnormalities in glycemic control that characterize diabetes mellitus can, over time, cause neuropathy and substantial microvascular and macrovascular changes. Structural changes, neuropathy, vascular insufficiency, pressure and infection all contribute to skin breakdown, ulceration, gangrene and amputation. Diabetic foot ulceration, a significant late-stage complication of diabetes, affects approximately 15% of diabetics and precedes 85% of diabetes-associated non-traumatic foot or leg amputations. The risk of amputation increases 10-fold among patients with both diabetes and end-stage renal disease.

Diabetic foot ulcers are a major cause of morbidity and hospitalization among people with diabetes. Although it is not possible to prevent all diabetic foot problems, the incidence and morbidity can be dramatically reduced through evidence-based prevention and management protocols. A systematic team approach implemented by a specialized interprofessional team can consistently improve limb salvage rates. This team needs to work closely with patients and their families to address lifestyle and self-care issues as well as to treat the ulcer. A careful history can identify issues associated with general health, diabetic control and complications, and factors that may cause ulceration or affect ulcer healing.

Identify and Treat the Cause Level of Evidence
1 Take a careful history (general history, diabetic control and complications) Not Assessed
2 Take a careful history to establish factors affecting skin breakdown or ulcer healing. Not Assessed

Essential Publications

1 Diabetes control Quality Indicator Type: Prospective Correlation study
Stratton IM, Cull CA, Adler AI, Matthews DR, Neil HAW, Holman RR. Additive effects of glycemia and and blood pressure exposure on risk of complications in type 2 diabetes: a prospective observational study (UKPDS 75). Diabetologia (2006);49:1761-1769.
This is a large prospective study involving 4320 patients with newly diagnosed type 2 diabetes who were investigated to determine if the associations between the risk of developing diabetes-related complications and various combinations of glycemia (HbA1c) and systolic blood pressure (SBP) levels over time is additive. The finding that there was an interaction between the effects of both risk factors on development of complications was corroborated in 887 subjects who participated in a randomized trial that offered various combinations of levels of control of glucose and blood pressure. This study indicates that hyperglycemia and hypertension are related independently and additively with the risk of complications of Type 2 diabetes and their effects. Clinicians must provide rigorous treatment of both risk factors to limit the occurrence of complications.
2 Diabetes control Quality Indicator Type: Correlation study
Stratton IM, Adler AI, Neil HA, Matthews DR, Manley SE, Cull CA, Hadden D, Turner RC, Holman RR. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ 2000;321(7258):405-12.
This is a large prospective study involving 4585 patients with newly diagnosed type 2 diabetes to determine the association between exposure to glycemia over time with the risk of macrovascular and microvascular complications. Endpoints included death related to diabetes and all-cause mortality, myocardial infarction, stroke, amputation, and microvascular disease. Each 1% reduction in HbA1c was associated with risk reduction for any endpoint of 21% (95% confidence interval 17% to 24%, P

Background: Management Principles

Diabetic foot ulcers are complex wounds, with several potential causative or contributing factors, which may be local, systemic or extrinsic. Three key aspects of the assessment and management of diabetic foot ulcers are vascular supply, infection and pressure redistribution.

Such complex clinical problems are best treated in the environment of a foot ulcer program using an interdisciplinary team that includes physicians, nurses and foot care experts. These teams require specific knowledge and skills competently to assess and manage diabetic foot ulcers and to integrate the best evidence for practice and expertise in wound care. Educating patients and involving them in both planning and implementing their care is empowering and can reduce ulcer recurrence. The interdisciplinary team managing foot ulcers plays an important role in educating patients about foot care and ulcer prevention. Managing foot ulcers effectively can significantly improve the quality of life of patients, families and caregivers.

A comprehensive diabetic foot ulcer program can increase healing of diabetic foot ulcers, improve quality of life and reduce amputation rates. Developing and implementing a successful diabetic foot ulcer program involves close collaboration between educators, practice leaders and administrators. Program outcomes should be monitored, evaluated and benchmarked to support a continuous quality improvement process.

Identify and Treat the Cause Level of Evidence
1 Care of diabetic foot ulcers should always include assessment and management of vascular supply, infection and pressure redistribution. Not Assessed
Address patient-centered Concerns Level of Evidence
2 Educate the patient appropriately and encourage him/her to participate in planning and implementing care. Not Assessed
3 The diabetic foot care team is responsible for ensuring that the patient receives appropriate education. Not Assessed
Provide Local Wound Care Level of Evidence
4 Develop and implement a comprehensive diabetic foot ulcer program. Not Assessed
5 Monitor, evaluate and benchmark outcomes of diabetic foot ulcer programs to increase ulcer healing, reduce amputations and improve quality of life. Not Assessed
Provide Organizational Support Level of Evidence
6 Assemble, train and support an interdisciplinary diabetic foot care team to manage diabetic foot ulcers. Not Assessed

Essential Publications

n/a

Diagnosis and Treatment of Neuropathy

The definition of diabetic neuropathy used for this summary is the following: • The presence of symptoms and/or signs of peripheral nerve dysfunction in people with diabetes, after exclusion of other causes.

Sensory neuropathy, present in 30 to 50% of people with diabetes, is the most important common cause of foot ulceration, and 45 to 60% of ulcerations are entirely neuropathic in origin. Motor and autonomic neuropathy may also contribute to the risk of ulceration. Distal symmetric sensorimotor neuropathy is the most common clinical presentation.

Presenting symptoms vary and may include various types of pain, altered temperature perception, paresthesia, hyperesthesia, allodynia or insensitivity. Nocturnal exacerbation may be present. Motor symptoms, such as weakness, may also be present. Some patients report no symptoms.

Neuropathy cannot be excluded without a neurologic examination. Various scoring measures exist, including the Neuropathy Disability Score and the Michigan Neuropathy Screening Instrument. The ankle reflex is often reduced or absent in people with diabetic neuropathy. Absent ankle reflexes are a useful predictor of ulceration risk.

Electrophysiologic testing is the most sensitive, reproducible and reliable method of evaluating nerve function, and such testing can also detect subclinical neuropathy. Electrophysiology does not diagnose the cause of the neuropathy.

Vibration perception threshold can be evaluated using a tuning fork (128Hz) or a biothesiometer, which can quantify and measure progressive sensory loss. A decreased vibration threshold is highly predictive of foot ulceration, with a threshold above 25V increasing risk tenfold compared with lower thresholds.

Semmes Weinstein monofilaments can identify loss of pressure sense. Absent protective threshold is diagnosed if an individual cannot feel at least seven of 10 tested pedal sides. A sensitive predictor of ulceration and amputation risk is inability to feel pressure of a 10-g monofilament.

Treatment of neuropathy is focused on maintaining a healthy foot and preventing ulceration. Treatment measures include management of any foot deformities, appropriate footwear, frequent professional monitoring and patient education about the importance of proper foot care and footwear and effective diabetes management.

Identify and Treat the Cause Level of Evidence
1 Conduct a foot inspection and examine for decreased sensation. Correct (if possible) risk factors for ulcer formation/amputation: Vascular supply Infection Pressure (including bony deformity) Remember the mnemonic VIP Not Assessed
2 Perform neurologic testing, even in patients with no symptoms, to diagnose or rule out diabetic neuropathy. Not Assessed
3 Identify risk of foot ulceration based on results of neurologic testing, including increased vibration threshold and inability to feel pressure of a 10-g monofilament. Not Assessed
Address Patient-centered Concerns Level of Evidence
4 Provide individualized education about plantar pressure redistribution/daily foot inspection. Not Assessed
5 Assess neuropathic pain and treat when required. Not Assessed
Provide Local Wound Care Level of Evidence
6 Follow recommended strategies to maintain a healthy foot in all patients with diabetic neuropathy. Not Assessed
Provide Organizational Support Level of Evidence
7 Establish and empower an interprofessional team to work with Persons With Diabetes (PWD) and neuropathy. Not Assessed

Essential Publications

1 Screening for diabetic peripheral neuropathy Quality Indicator Type: Validation study
Perkins BA, Olaleye D, Zinman B, Bril V. Simple Screening Tests for Peripheral Neuropathy in the Diabetes Clinic. Diabetes Care2001;24(2):250-256.
The diagnostic properties of the Semmes-Weinstein monofilament examination (SWME), superficial pain sensation, vibration testing (on-off method), and vibration testing (timed method) were determined by comparison with the reference standard of electrophysiological tests for the diagnosis of peripheral neuropathy. The likelihood ratio for an abnormal test for each of the screening tests indicates that all tests are useful in detecting peripheral neuropathy: vibration (on-off method) 26.6, vibration (timed) 18.5, monofilament 10.2, superficial pain 9.2. The combination of two tests did not improve diagnosis.
2 Walking for people with diabetic peripheral neuropathy Quality Indicator Type: Correlation study
Kanade RV, van Deursen M, Harding K, Price P. Walking performance in people with diabetic neuropathy: benefits and threats. Diabetologia 2006;49:1747-1754.
In this study, total heart beat index, gait velocity, and average daily strides were determined in several patient groups: those with diabetic neuropathy, with diabetic foot ulcers, with partial foot amputations, and with trans-tibial amputations. In patients with more foot complications, total heart beat index increased, and gait velocity and daily stride count decreased. It was concluded that walking should be recommended only with protective footwear.
3 Recombinant human platelet-derived growth factor Quality Indicator Type: Cohort study (2 groups)
Margolis DJ, Bartus C, Hoffstad O, Malay S, Berlin JA. Effectiveness of recombinant human platelet-derived growth factor for the treatment of diabetic neuropathic foot ulcers. Wound Repair Regen. 2005 Nov-Dec;13(6):531-6.
The purpose of this study is to evaluate the effectiveness of recombinant human platelet-derived growth factor (rhPDGF) in the treatment of diabetic neuropathic foot ulcers. 24,898 individuals were included, of whom 9.6% received treatment with rhPDGF. The results showed that rhPDGF is effective in both promoting healing of diabetic foot ulcers and in preventing lower-extremity amputations, compared to standard therapy.
4 Recombinant human platelet-derived growth factor Quality Indicator Type: RCT
Steed DL. Clinical evaluation of recombinant human platelet-derived growth factor for the treatment of lower extremity ulcers. Plast Reconstr Surg. 2006 Jun;117(7 Suppl):143S-149S; discussion 150S-151S.
This study compares recombinant human platelet-derived growth factor and a placebo in the treatment of chronic neuropathic diabetic foot ulcers. The results show that the recombinant human platelet-derived growth factor increases healing rate and decreases time to complete healing. Adverse effects and ulcer recurrence were similar for both groups. This shows that recombinant human platelet-derived growth factor is an effective treatment strategy for diabetic foot ulcers and can be used clinically.
5 Graftskin in the treatment of Diabetic Foot Ulcers Quality Indicator Type: RCT
Veves A, Falanga V, Armstrong DG, Sabolinski ML; Apligraf Diabetic Foot Ulcer Study. Graftskin, a human skin equivalent, is effective in the management of noninfected neuropathic diabetic foot ulcers: a prospective randomized multicenter clinical trial. Diabetes Care. 2001 Feb;24(2):290-5.
This study examined the effect of graftskin on the healing of noninfected nonischemic chronic plantar diabetic foot ulcers. The results showed that graftskin facilitated improved healing than other current therapies, with no associated side-effects. Consequently, graftskin can be used clinically as an adjunctive therapy for diabetic foot ulcers.

Infection

Infection is frequently associated with the diabetic foot. Undetected small erosions may become infected and develop into local cellulitis or lymphadentitis. Loss of protective sensation makes a daily foot examination critical for early detection of infection. One study found a handheld infrared skin temperature monitoring device for home use to be effective in identifying early warning signs of inflammation and tissue injury. Patients not using the device had more than ten times the foot complication rate of patients using the device.

All skin ulcers are contaminated with bacteria, and more than three bacterial species are usually found in chronic wounds. As a result, swabbing and culturing an infected wound does not reliably identify causative organisms. Microbial flora in a chronic wound change predictably over time. Over the first few days, only cutaneous flora are found in the wound. From 1 to 4 weeks, these flora are accompanied by Gram-positive aerobic cocci, often beta-hemolytic Streptococci and Staphylococcus aureus. A purulent discharge may be present. After 4 weeks, cutaneous flora are accompanied by Gram-negative facultative anaerobic bacteria, especially coliforms, anaerobes and Psuedomonas. Tissue necrosis, undermining and deep tissue involvement may be seen clinically.

The signs of chronic infection differ from those associated with acute infection. Changes in odour, colour, tissue quality and exudate are seen in infected diabetic wounds. Validated signs and symptoms of chronic wound infection include the following:

  • Increased pain (100% specificity)
  • Wound breakdown (100% specificity)
  • Foul odour (85% specificity)
  • Friable granulation tissue (76% specificity).

Deep tissue infection often results in warmth and erythema extending 2 cm beyond the wound margin. It is necessary to probe undermined wounds and those with sinus tracts, as contact with bone or ligaments indicates osteomyelitis. Signs of deep or systemic infection indicate a potentially limb-threatening or life-threatening situation, which demands immediate attention.

Wound cultures, although not diagnostic for infection, can provide information about predominant flora to guide antibiotic selection for treatment of non-healing or deteriorating wounds with heavy exudate. Blood culture is appropriate if sepsis is suspected. Levels of C-reactive protein tend to increase in severe infection. A white blood cell count and erythrocyte sedimentation rate may indicate sepsis, but normal values do not rule out infection. Radiography is a useful initial investigation to detect osteomyelitis, gas, foreign bodies and bony abnormalities. Bone destruction takes 10 to 21 days to be apparent after infection. Gallium scanning, computed tomography, and magnetic resonance imaging may be ordered to detect infection not evident on plain films or to confirm the diagnosis.

Identify and Treat the Cause Level of Evidence
1 Take a careful history (general history, diabetic control and complications). Not Assessed
2 Conduct a foot inspection and examine for decreased sensation. Correct (if possible) risk factors for ulcer formation/amputation:§ Vascular supply§ Infection§ Pressure (including bony deformity)Remember the mnemonic VIP Not Assessed
3 It is critical that clinicians are able to recognize the clinical signs of superficial and deep infection in diabetic foot ulcers, as culture is an unreliable indicator of infection. Not Assessed
4 Culture infected diabetic foot ulcers to determine the predominant organisms and guide selection of antibiotic therapy. Not Assessed
5 Perform blood cultures if sepsis is suspected. Not Assessed
6 Laboratory tests may be used to support clinical findings of infection. Not Assessed
7 Imaging studies may be used to detect bone involvement and to confirm the diagnosis. Not Assessed
Address patient-centered Concerns Level of Evidence
8 Provide individualized education to enhance Glycemic control, Adherence to treatment, Plantar pressure redistribution/daily foot inspection. (GAP) Not Assessed
Provide Local Wound Care Level of Evidence
9 Optimize wound healing environment through Debridement, Infection (bacterial burden control) and Moisture balance. (DIM) Not Assessed
Provide Organizational Support Level of Evidence
10 Establish and empower an interprofessional team to work with Persons With Diabetes (PWD). Not Assessed

Essential Publications

1 Infection Quality Indicator Type: CPG (Clinical Practice Guideline)
Lipsky BA. A report from the international consensus on diagnosing and treating the infected diabetic foot. Diabetes/Metabolism Research and Reviews 2004; 20(Suppl 1): S68-S77.
This CPG is specifically concerned with guiding the treatment of infections. There are approximately 20 recommendations, of which 4 are based on level I evidence and 6 are based on level II-III, the rest are III to IV.
2 Infection Quality Indicator Type: Systematic review
Nelson EA, O’Meara S, Craig D, Iglesias C, Golder S, Dalton J, et al. A series of systematic reviews to inform a decision analysis for sampling and treating infected diabetic foot ulcers. Health Technol Assess 2006;10(12).
This very well conducted systematic review that indicated that infection in DFUs cannot be reliably identified using clinical assessment and provided no strong evidence for recommending any particular antimicrobial agents for the prevention of amputation, resolution of infection or ulcer healing.
3 Diagnosis of Infection Quality Indicator Type: Systematic review
O’Meara S et al.. Systematic reviews of methods to diagnose infection in foot ulcers in diabetes.. Diabet. Med. 23, 341–347 (2006)
This systematic review of cross sectional studies was conducted to explore the diagnostic performance of clinical examination, sample acquisition and sample analysis in infected foot ulcers in diabetes. The study is important for demonstrating that the evidence is weak. Thus, we are encouraged to determine better methods of diagnosing infection in foot ulceration in people with diabetes.
4 Infection risk factors Quality Indicator Type: RCT
Lavery LA, Armstrong DG, Wunderlich RP, Mohler MJ, Wendel CS, Lipsky BA. Risk factors for foot infections in individuals with diabetes. Diabetes Care 2006;29:1288-1293.
Over a 2 year period, 1666 consecutive patients with diabetes were had a standardized general medical examination, a detailed foot exam and received education for proper foot care. The following independent variables (risk ratios) were found by multivariate analysis to be risk factors for foot infections: wound depth to bone (6.7), wound duration > 30 days (4.7), recurrent foot wound (2.4), traumatic wound etiology (2.4), and peripheral vascular disease (1.9). This paper will be useful to clinicians who need to know the characteristics of patients who are likely to develop infections.
5 Ischemia and infection in patients with diabetic foot disease Quality Indicator Type: Narrative Review
Prompers L, Huijberts M, Apelqvist J, Jude E, Piaggesi A, Bakker K, Edmonds M, Holstein P, Jirkovska A, Mauricio D, Ragnarson Tennvall G, Reike H, Spraul M, Uccioli L, Urbancic V, Van Acker K, van Baal J, van Merode F, Schaper N. High prevalence of ischaemia, infection and serious comorbidity in patients with diabetic foot disease in Europe. Baseline results from the Eurodiale study. Diabetologia. 2007 Jan;50(1):18-25. Epub 2006 Nov 9.
This publication demonstrates that severity of diabetic foot ulcers at presentation is greater than previously reported. It also demonstrated that serious comorbidities are associated with increasing severity of foot disease. Finally, the study underscores the need for future research to examine clinical outcomes.
6 Surgical versus antimicrobial Treatment for Osteomyelitis Quality Indicator Type: Narrative Review
Jeffcoate WJ, Lipsky BA. Controversies in diagnosing and managing osteomyelitis of the foot in diabetes. Clin Infect Dis. 2004 Aug 1;39 Suppl 2:S115-22.
This publication compares surgical and antimicrobial treatment strategies in the management of osteomyelitis. It presents the benefits and shortcomings of each approach, and concludes that both are viable and important treatment strategies for osteomyelitis.
7 Non-surgical osteomyelitis management Quality Indicator Type: Narrative Review
Game FL, Jeffcoate WJ. Primarily non-surgical management of osteomyelitis of the foot in diabetes. Diabetologia. 2008 Jun;51(6):962-7. Epub 2008 Apr 3.
The authors acknowledge that further research is necessary, but the results suggest that non-surgical management is beneficial in most cases. In cases where urgent surgery is not absolutely required, the results show optimized effects through non-surgical management.
8 Non-surgical osteomyelitis management Quality Indicator Type: Cohort study (2 groups)
Senneville E, Lombart A, Beltrand E, Valette M, Legout L, Cazaubiel M, Yazdanpanah Y, Fontaine P. Outcome of diabetic foot osteomyelitis treated nonsurgically: a retrospective cohort study. Diabetes Care. 2008 Apr;31(4):637-42. Epub 2008 Jan 9.
The results of this study demonstrate that bone culture based antibiotic therapy is effective in preventing remission in diabetic patients treated non-surgically for osteomyelitis.
9 Bacteriological Diagnosis of Osteomyelitis Quality Indicator Type: Longitudinal study (1 group)
Kessler L, Piemont Y, Ortega F, Lesens O, Boeri C, Averous C, Meyer R, Hansmann Y, Christmann D, Gaudias J, Pinget M. Comparison of microbiological results of needle puncture vs. superficial swab in infected diabetic foot ulcer with osteomyelitis. Diabet Med. 2006 Jan;23(1):99-102.
This study examines the effectiveness of needle puncture and superficial swabbing in detecting osteomyelitis in diabetic patients with foot ulcers. The results showed that needle puncture is a generally effective technique, and should be used when surgical debridement is contraindicated.
10 Tetanus Prophylaxis Quality Indicator Type: Narrative Review
Rogers LC, Frykberg RG. Tetanus prophylaxis for diabetic foot ulcers. Clin Podiatr Med Surg. 2006 Oct;23(4):769-75, vii-i.
This publication examines the possibility of tetanus infection in diabetic foot wounds. In order to combat this issue, the publication asserts that all patients with diabetic foot wounds should receive tetanus prophylaxis.

Local Wound Care

Effective management of diabetic foot ulcers requires initial and ongoing assessment of the wound and creation and maintenance of an optimal environment for healing.

Assessment It is important to use an accepted wound classification system, such as the Wagner system or the University of Texas classification. All clinicians caring for the patient should use the same wound measurement and ulcer grading system, including assessment for infection and ischemia. The University of Texas staging system is correlated with the risk of adverse outcomes, including amputation.

Area: A 20 to 40% reduction in ulcer area after 2 to 4 weeks of treatment predicts healing. Reliability in measuring healing in based on consistent measurement methods, such as tracing and/or the use of measurement tools.

Depth: Ulcer depth, undermining and tunnelling are most commonly measured using a sterile probe. An accepted standard for wound photography and digital imaging does not yet exist, although these approaches are increasingly used for wound assessment.

Infection: Validated signs and symptoms of chronic wound infection include increased pain, wound breakdown, foul odour and friable granulation tissue. Deep or systemic infection indicates a potentially limb-threatening or life-threatening situation, which demands immediate attention.

Optimum environment Effective local wound care requires an optimal environment for healing, which can be achieved by performing appropriate debridement, controlling infection and maintaining appropriate moisture balance in the wound. Adequacy of vascular supply for wound healing must be determined prior to implementing aggressive debridement and moist interactive dressings.

Debridement: Debridement of infected and/or contaminated tissue and of nonviable tissue from the wound bed improves healing rates of diabetic ulcers. Callus debridement around the wound can reduce local pressure by approximately 30%. Autolytic, mechanical, sharp and surgical debridement methods are used most frequently for diabetic foot ulcers.

Infection control: Host defences can usually manage colonized wounds, but critically colonized wounds may not progress toward healing and may show signs of distress. Removal of eschar, an ideal environment for bacterial growth, rapidly improves the microbial environment. If debridement fails to improve the wound environment, a topical antimicrobial may help to rebalance host defences. Antimicrobials should be selected empirically to treat the predominant organism expected, based on the normal progression of bacterial colonization in chronic wounds. As chronic wound flora are polymicrobial, a broad-spectrum antimicrobial agent should be selected to control all organisms while providing no survival advantage to specific organisms. If a 2-week course of treatment does not improve the wound environment, systemic therapy targeting the most likely organism is indicated.

Moisture balance: Clinicians should understand dressing categories and their characteristics in order to select dressings that keep the wound bed moist and the surrounding skin dry, that control exudate, eliminate dead space and minimize trauma and infection risk. The patient and caregiver must understand the need for reduced pressure on the wound.

The clinical team should assess the wound frequently to determine the effectiveness of the treatment plan.

Identify and Treat the Cause Level of Evidence
1 Take a careful history (general history, diabetic control and complications). Not Assessed
2 Conduct a foot inspection and examine for decreased sensation. Correct (if possible) risk factors for ulcer formation/amputation:§ Vascular supply§ Infection§ Pressure (including bony deformity)Remember the mnemonic VIP Not Assessed
3 Select and consistently apply an accepted wound classification system to assess diabetic foot ulcers. Not Assessed
4 Assess wound area, depth and infection initially to determine a treatment plan and regularly to determine its effectiveness. Not Assessed
Address patient-centered Concerns Level of Evidence
5 Provide individualized education to enhance Glycemic control, Adherence to treatment, Plantar pressure redistribution/daily foot inspection. (GAP) Not Assessed
6 Provide patient and caregiver education about the need for reduced wound pressure to support healing. Not Assessed
Provide Local Wound Care Level of Evidence
7 Assess and document healing with ulcer duration, location, size, and depth (probe to bone). Not Assessed
8 Optimize wound healing environment through Debridement, Infection (bacterial burden control) and Moisture balance. (DIM) Not Assessed
9 For stalled wounds, consider the use of biological agents and adjunctive therapies (edge effect). DIM/E Not Assessed
10 Debride infected and/or contaminated nonviable tissue using an appropriate debridement method. Not Assessed
11 Provide an optimum environment for wound healing with attention to debridement, infection control and moisture balance. Not Assessed
12 Control wound bacterial balance using debridement and broad-spectrum topical antimicrobials if necessary. Not Assessed
13 Institute systemic antimicrobial therapy if a 2-week course of topical treatment does not improve the wound environment. Not Assessed
14 Select wound dressings that provide a moist wound environment, control exudate, keep surrounding skin dry, eliminate dead space, and minimize trauma and infection risk. Not Assessed
Provide Organizational Support Level of Evidence
15 Establish and empower an interprofessional team to work with Persons With Diabetes (PWD). Not Assessed

Essential Publications

1 Adjunctive therapy – Electrical stimulation Quality Indicator Type: RCT
Peters EJ, Lavery LA, Armstrong DG, Fleischli JG. Electric Stimulation as an Adjunct to Heal Diabetic Foot Ulcers: A Randomized Clinical Trial. Arch Phys Med Rehabil 2001;82:721-5.
This is a well conducted randomized double-blind placebo-controlled study of the effect of electrical stimulation delivered through a micro-computer for 8 hours every night on healing diabetic foot ulcers. There were only 20 patients per group with University of Texas grade 1A-2A ulcers who, in addition to electrical stimulation or placebo, received debridement, topical hydrogel, and removable cast walkers for off-loading, and were followed for 12 weeks or until healed. Although there was not a significant difference between the proportions healed in the treatment and placebo groups, 65% versus 35% (P=0.058), this could have been due to insufficient statistical power. In both groups, compliant subjects healed more often than noncompliant (P=0.038). Although a larger sample size is needed for significance, this study suggests that more subjects who received electrical stimulation rather than placebo, in addition to debridement, topical hydrogel and pressure offloading, experienced wound healing.
2 Silver dressings Quality Indicator Type: Systematic review
Bergin, S.M. & Wraight, P. Silver based wound dressings and topical agents for treating diabetic foot ulcers. Cochrane Database of Systematic Reviews 2006, Issue 1. Art. No.:CD005082. DOI: 10.1002/14651858.CD005082.pub2
This systematic review was conducted to evaluate the effects of silver-containing dressings and topical agents on infection rates and healing of diabetes related foot ulcers in people with Type 1 or Type 2 diabetes and related foot ulcers. Despite good search methodology, no appropriately randomized and controlled trials evaluating the effect of silver based products on infection and healing of diabetic foot ulcers were found. This study is important in demonstrating the need for rigorous RCTs evaluating silver dressings.
3 Silver dressings Quality Indicator Type: Systematic review
Vermeulen, H., van Hattem, J.M., Storm-Versloot, M.N., Ubbink, D.T: Topical silver for treating infected wounds. Cochrane Database of Systematic Reviews 2007, Issue 1. Art. No.: CD0005486. DOI: 10.1002/14651858.CD005486.pub2.
This well-conducted systematic review that included 3 RCTs was conducted to evaluate the effects on wound healing of topical silver and silver dressings in the treatment of contaminated and infected acute or chronic wounds. None of the trials demonstrated clear evidence increased healing rates resulting from the application of topical silver. This recent systematic review suggests that there is a lack of good-quality clinical evidence regarding the effectiveness of silver in treating infected wounds.
4 Silver dressings Quality Indicator Type: RCT
Jude EB, Apelqvist J, Spraul M, Mastini J and the Silver Dressing Study Group. Prospective randomized controlled study of Hydrofiber® dressing containing ionic silver or calcium alginate dressings in non-ischaemic diabetic foot ulcers. Diabetic Medicine 2007; 24(3):280-8.
In this study the safety and efficacy of AQUACEL® Hydrofiber® dressings containing ionic silver (AQAg) were compared with dressings of Algosteril® calcium alginate (CA) for managing outpatients with Type 1 or 2 diabetes mellitus and non-ischaemic Wagner Grade 1 or 2 diabetic foot ulcers. Subjects received similar protocols including off-loading and AQAg (n=67) vs CA (n=67) as primary dressings and secondary foam dressings for 8 weeks or until healed. There was no difference between the groups in the mean time to heal, AQAg 53 versus 58 days (P=0.34) but there was greater reduction in ulcer depth AQAg 0.25 cm versus 0.13 cm (P=0.04). Readers should be aware of potential bias in this unblinded but otherwise well-conducted study that was supported by a clinical grant from ConvaTec.
5 Debridement Quality Indicator Type: Systematic review
Smith J. Debridement of diabetic foot ulcers. Cochrane Database of Systematic Reviews 2002, Issue 4. Art. No.: CD003556. DOI:10.1002/14651858.CD003556.
In this well conducted systematic review based on 5 RCTs, various methods of debridement were compared with gauze or standard wound care for their effect on proportion of people whose ulcers healed completely and time to complete healing. Although hydrogels were found to be significantly more effective than standard care in healing diabetic foot ulcers (Relative Risk 1.84, 95% Confidence Interval 1.3 to 2.6), it was not clear that if the results were due to the moist healing environment or to the debriding function of hydrogels. The RCTs were not large enough to show a beneficial effect of either surgical debridement or larval therapy.
6 Debridement Quality Indicator Type: Systematic review
Bradley M, Cullum N, Sheldon T. The debridement of chronic wounds: a systematic review. Health Technology Assessment 1999; Vol. 3: No. 17 (Pt 1)
This is a large well conducted systematic review of debriding interventions based on 35 RCTs that were described by the authors as being of generally poor quality. The interventions dextanomer polysaccharide beads or paste, cadexomer iodine polysaccharide beads or paste, hydrogels, enzymatic agents, adhesive zinc oxide tape, surgery or sharp debridement, and larval (maggot) therapy were investigated. Due to heterogeneity of studies, the results were not pooled. No RCTs were found that evaluated the effectiveness of surgical debridement, larval therapy, or debridement compared with no debridement. There was insufficient evidence to promote the use of one debriding agent over another.
7 Debridement Quality Indicator Type: RCT
Steed DL, Donohoe D, Webster MW, Lindsley L, and the Diabetic Ulcer Study Group. Effect of Extensive debridement and treatment on the healing of diabetic foot ulcers. J Am Coll Surg 1996; 183:61-64.
This is a landmark article that is cited to support the use of debridement in the treatment of diabetic foot ulcers. Although this RCT was designed to evaluate the efficacy of topically applied recombinant human platelet derived growth factor (rhPDGF) compared with placebo, perhaps the most important finding was that the healing rate was greater in the facilities that practiced adequate debridement (acute wound in a chronic wound) irrespective of treatment group.
8 Hyperbaric Oxygen Therapy (HBOT) Quality Indicator Type: Systematic review
Berendt AR. Counterpoint: Hyperbaric Oxygen for Diabetic Foot Wounds Is Not Effective, 2006, Clinical Infectious Diseases, 43:193-8.
This systematic review involving 4 RCTs was conducted to examine the effect of HBOT on the number of diabetic foot wounds healed and amputations performed. In three out of the four studies, wounds were not healed. Minor amputations were performed in two out of the four studies and major amputations were performed in three out of four studies. This review indicates the need for statistically powered RCTs with adequate blinding to demonstrate the efficacy and cost effectiveness of HBOT in healing ulcers and preventing major amputations.
9 Hyperbaric Oxygen Therapy (HBOT) Quality Indicator Type: Systematic review
Kranke P, Bennett M, Roeckl-Wiedmann I, Debus S. Hyperbaric oxygen therapy for chronic wounds. Cochrane Database of Systematic Reviews 2004, Issue 1. Art. No.: CD004123. DOI: 10.1002/14651858.CD004123.pub2.
This well-conducted systematic review involving 4 RCTs was undertaken to determine the benefits and harms of adjunctive HBOT in people with diabetic foot ulcers. There was no statistically significant increase in the proportion of ulcers healed following HBOT. However, there was a significant reduction in risk of major amputation with HBOT compared with alternative therapy (RR 0.31, 95% CI 0.13 to 0.71.) One would need to treat 4 individuals with HBOT to prevent one amputation (NNT 4, 95% CI 3 to 11). There was no significant change in rates of minor amputation. This study provides limited evidence that HBOT reduces the rate of major amputation in people who have chronic foot ulcers as a result of diabetes, but more rigorous studies are needed to corroborate these findings.
10 Hyperbaric Oxygen Therapy (HBOT) Quality Indicator Type: Systematic review
Hailey D, Jacobs P, Perry DC, Chuck A, Morrison A, Boudreau R. Adjunctive Hyperbaric Oxygen Therapy for Diabetic Foot Ulcer: An Economic Analysis [Technology report no 75]. Ottawa: Canadian Agency for Drugs and Technologies in Health; 2007.
This well-conducted systematic review that involves RCTs and non-randomized controlled trials was undertaken to determine if adjunctive HBOT is a cost-effective option compared with standard care for treating patients with DFU in Canada. A lower proportion of major lower extremity amputations occurred in patients who received adjuntive HBOT as opposed to standard care alone. One study showed that the reduction in wound surface area was significantly greater in the HBOT group than in the control group. This review demonstrates limited evidence of the effectiveness of HBOT in treating diabetic foot ulcers.
11 Hyperbaric Oxygen Therapy (HBOT) Quality Indicator Type: Systematic review
Roeckl-Wiedmann I, Bennett M and Kranke P. Systematic review of hyperbaric oxygen in the management of chronic wounds.. British Journal of Surgery 2005; 92: 24–32
This systematic review of 5 RCTs on people with diabetes and foot ulcers indicates that the risk of major amputation is reduced following HBOT but minor amputation is not. One RCT demonstrated significantly more ulcers healed following a course of HBOT compared with standard wound care at one year. Wound size was also reduced significantly by 20% immediately after a course of HBOT, but not at follow-up 4 weeks later. Transcutaneous oxygen tensions (TcPO2) were significantly higher in the HBOT group at the end of treatment. More rigorous RCTs with appropriate blinding are needed to determine the effect of HBOT on wound healing.
12 Hyperbaric Oxygen Therapy (HBOT) Quality Indicator Type: Systematic review
Medical Advisory Secretariat, Ontario Ministry of Health and Long Term Care, Hyperbaric Oxygen Therapy for Non-Healing Ulcers in Diabetes Mellitus. Health Technology Literature Review. September 2005.
This well-conducted systematic review of health technology assessments (published and grey literature), systematic reviews and RCTs was undertaken to assess the effectiveness, safety, and cost-effectiveness of HBOT, either alone or as an adjunct, compared with the standard treatments for non-healing foot or leg ulcers in patients with DM. Wound healing, prevention of minor or major amputation, and transcutaneous oxygen tension measurements were investigated. This review provides endorsement of the Cochrane review (Roeckl-Wiedmann et al, 2005) of HBOT 2005 that indicates that HBOT reduced the risk of major amputation but not minor amputation and points out the need for a rigorous RCT with wound healing and amputation as the outcomes in persons with diabetes and foot ulcers.
13 Chronic wound treatments: rationale for wound type specific treatment Quality Indicator Type: Systematic review
Lau J, Tatsioni A, Balk E, Chew P, Kupelnick B, Wang C and O’Donnell T. Usual Care in the Management of Chronic Wounds: A Review of the Recent Literature. AHRQ Technology Assessment Program. March 8, 2005.
The purpose of this systematic review was to determine from RCTs the usual care given to control group patients in clinical trials of chronic wound management as a proxy for standard care; the common elements of wound care across different types of wounds; and the treatment modalities that are unique for each type of chronic wound. Information was obtained also from clinical practice guidelines, and selected surgical textbooks. This review provides comprehensive background and rationale for various treatment approaches for different wound types.
14 Antibacterial therapy – optimizing treatment Quality Indicator Type: Narrative Review
Rao N, Lipsky BA. Optimising antimicrobial therapy in diabetic foot infections. Drugs. 2007;67(2):195-214.
This review of RCTs and observational studies was conducted to examine the effect of antibacterial therapy on diabetic foot infections by examining the rate of major amputations, healing rate, and need for surgical intervention. Although this article is not a systematic review, it provides a good overview of antimicrobial therapy with numerous RCTs and observational studies summarized to provide an evidence-based approach to infection management for people with diabetes and foot ulcers. Perhaps this article would be useful as an enabler.
15 Wound management and antibacterial therapy Quality Indicator Type: Systematic review
O’Meara S, Cullum N, Majid M and Sheldon T. Systematic reviews of wound care management: (3) antimicrobial agents for chronic wounds; (4) diabetic foot ulceration. Health Technology Assessment 2000; Vol. 4: No. 21
This is a well-conducted systematic review of RCTs and controlled clinical trials undertaken to assess the clinical- and cost-effectiveness of prevention and treatment strategies for diabetic foot ulcers and to assess systemic and topical antimicrobial agents in the prevention and healing of chronic wounds. The results were too variable to combine and were reported narratively. Significant results were related to use of an orthotic device to reduce callus grade, wearing of stockings to reduce ulceration at year 4; wearing of total contact cast to promote ulcer healing and reduce time to heal; use of dermagraft to promote complete healing by 12 weeks; treatment with HBOT to reduce the rate of amputation and save limbs; the use of ketanserin to reduce ulcer area; the use of rhPDGF-BB gel versus placebo gel to produce wound healing; the use of Arginine-glycine-aspartic acid peptide matrix versus placebo to produce wound healing. Although it is not recent, this overview indicates the individual articles that demonstrate significant findings.
16 Vacuum assisted closure (VAC) therapy Quality Indicator Type: Systematic review
Pham C, Middleton P and Maddern G. Vacuum-assisted closure for the management of wounds: an accelerated systematic review. December 2003.
This systematic review of RCTs, non-randomized comparative studies and case series, was conducted to determine the efficacy and safety of managing non-healing wounds using VAC therapy with conventional methods. Foot ulcers were reduced by 28.4% when treated by VAC as compared with saline-moistened gauze that increased by 9.5% (P=0.004). This systematic review suggests that VAC therapy is efficacious for the treatment of diabetic foot ulcers.
17 Negative pressure wound therapy Quality Indicator Type: RCT
Blume PA, Walters J, Payne W, Ayala J, Lantis J. Comparison of negative pressure wound therapy utilizing vacuum-assisted closure to advanced moist wound therapy in the treatment of diabetic foot ulcers – a multicenter randomized controlled trial. Diabetes Care. E-published 2007 Dec 12.
This is a large well-designed multicenter RCT involving 342 patients with diabetes and foot ulcers who were randomly allocated to negative pressure wound therapy (NPWT) or advanced moist wound therapy (AMWT). 43.2% of patients receiving NPWT versus 28.9% of patients receiving AMWT experienced complete ulcer closure (p=0.007). The ulcers of patients receiving NPWT closed significantly more quickly than those receiving AMWT (p=0.001) and there were fewer secondary amputations. There was not a significant difference between groups in infections, cellulites, or osteomyelitis at 6 months.
18 Negative pressure wound therapy Quality Indicator Type: RCT
Armstrong DG, Lavery LA for the Diabetic Foot Study Consortium. Negative pressure wound therapy after partial diabetic foot amputation: a multicentre, randomised controlled trial. Lancet 2005;366(9498:1704-1710.
This is one of the first RCTs illustrating that more patients who were treated with NPWT than standard wound therapy experienced healing, 56% versus 39% (p=0.04) and the rate of healing was significantly faster (p=0.005). The occurrence and severity of adverse events in this 16 week multicentre trial involving 162 patients was similar between the groups.
19 Skin Grafting for Diabetic Foot Ulcers Quality Indicator Type: RCT
Veves A, Falanga V, Armstrong DG, Sabolinski ML; Apligraf Diabetic Foot Ulcer Study. Graftskin, a human skin equivalent, is effective in the management of noninfected neuropathic diabetic foot ulcers: a prospective randomized multicenter clinical trial. Diabetes Care. 2001 Feb;24(2):290-5.
The purpose of this clinical trial was to evaluate skin grafting vs. standard care in the treatment of diabetic foot ulcers. After a 12 week period, the results showed that the grafting group experienced improved healing (P=0.0042). This demonstrates that grafting can be an effective adjunctive therapy in clinical practice.
20 Ultrasound Therapy Quality Indicator Type: RCT
Ennis WJ, Foremann P, Mozen N, Massey J, Conner-Kerr T, Meneses P. Ultrasound therapy for recalcitrant diabetic foot ulcers: results of a randomized, double-blind, controlled, multicenter study. Ostomy Wound Manage. 2005 Aug;51(8):24-39.
This study examines the effect of ultrasound therapy in the treatment of recalcitrant, diabetic foot ulcers. The results showed that therapeutic ultrasound is able to increase the rate of healing of recalcitrant, diabetic foot ulcers, and therefore can be used clinically as a treatment strategy
21 Promogran in the treatment of Diabetic Foot Ulcers Quality Indicator Type: RCT
Veves A, Sheehan P, Pham HT. A randomized, controlled trial of Promogran (a collagen/oxidized regenerated cellulose dressing) vs standard treatment in the management of diabetic foot ulcers. Arch Surg. 2002 Jul;137(7):822-7.
This study examined whether Promogran is more effective than moistened gauze in the treatment of diabetic foot ulcers. The results showed that both Promogran and moistened gauze has similar effects and safety profiles in the treatment of diabetic foot ulcers, but patient satisfaction was greater with Promogran. Therefore, Promogran can be effectively used in a clinical setting for the management of diabetic foot ulcers
22 Treatment for Diabetic Foot Ulcers Quality Indicator Type: Narrative Review
Cavanagh PR, Lipsky BA, Bradbury AW, Botek G. Treatment for diabetic foot ulcers. Lancet. 2005 Nov 12;366(9498):1725-35.
This publication provides a summary of the different treatment options available for diabetic foot ulcers. It outlines each of the management strategies, details benefits and shortcomings, and describes when each is appropriate

Neuropathy

The definition of diabetic neuropathy used for this summary is the following:

  • The presence of symptoms and/or signs of peripheral nerve dysfunction in people with diabetes, after exclusion of other causes.

Sensory neuropathy, present in 30 to 50% of people with diabetes, is the most important common cause of foot ulceration, and 45 to 60% of ulcerations are entirely neuropathic in origin. Motor and autonomic neuropathy may also contribute to the risk of ulceration. Distal symmetric sensorimotor neuropathy is the most common clinical presentation.

Presenting symptoms vary and may include various types of pain, altered temperature perception, paresthesia, hyperesthesia, allodynia or insensitivity. Nocturnal exacerbation may be present. Motor symptoms, such as weakness, may also be present. Some patients report no symptoms.

Neuropathy cannot be excluded without a neurologic examination. Various scoring measures exist, including the Neuropathy Disability Score and the Michigan Neuropathy Screening Instrument. The ankle reflex is often reduced or absent in people with diabetic neuropathy. Absent ankle reflexes are a useful predictor of ulceration risk.

Electrophysiologic testing is the most sensitive, reproducible and reliable method of evaluating nerve function, and such testing can also detect subclinical neuropathy. Electrophysiology does not diagnose the cause of the neuropathy.

Vibration perception threshold can be evaluated using a tuning fork (128Hz) or a biothesiometer, which can quantify and measure progressive sensory loss. A decreased vibration threshold is highly predictive of foot ulceration, with a threshold above 25V increasing risk tenfold compared with lower thresholds.

Semmes Weinstein monofilaments can identify loss of pressure sense. Absent protective threshold is diagnosed if an individual cannot feel at least seven of 10 tested pedal sides. A sensitive predictor of ulceration and amputation risk is inability to feel pressure of a 10-g monofilament.

Treatment of neuropathy is focused on maintaining a healthy foot and preventing ulceration. Treatment measures include management of any foot deformities, appropriate footwear, frequent professional monitoring and patient education about the importance of proper foot care and footwear and effective diabetes management.

Identify and Treat the Cause Level of Evidence
1 Conduct a foot inspection and examine for decreased sensation. Correct (if possible) risk factors for ulcer formation/amputation: Vascular supply Infection Pressure (including bony deformity) Remember the mnemonic VIP Not Assessed
2 Perform neurologic testing, even in patients with no symptoms, to diagnose or rule out diabetic neuropathy. Not Assessed
3 Identify risk of foot ulceration based on results of neurologic testing, including increased vibration threshold and inability to feel pressure of a 10-g monofilament. Not Assessed
Address patient-centered Concerns Level of Evidence
4 Provide individualized education to enhance Glycemic control, Adherence to treatment, Plantar pressure redistribution/daily foot inspection. (GAP) Not Assessed
Provide Local Wound Care Level of Evidence
5 Follow recommended strategies to maintain a healthy foot in all patients with diabetic neuropathy. Not Assessed
Provide Organizational Support Level of Evidence
6 Establish and empower an interprofessional team to work with Persons With Diabetes (PWD) and neuropathy. Not Assessed

Essential Publications

1 Prevention and Management of Diabetic Neuropathy Quality Indicator Type: Narrative Review
Unger J, Cole BE. Recognition and management of diabetic neuropathy. Prim Care. 2007 Dec;34(4):887-913, viii.
This publication provides a thorough and comprehensive summary of information relevant to diabetic neuropathy. It is a good source of information for researchers and practitioners who wish to learn about diabetic neuropathy.
2 Detection of Diabetic Foot Neuropathy Quality Indicator Type: Prospective Correlation study
Forouzandeh F, Aziz Ahari A, Abolhasani F, Larijani B. Comparison of different screening tests for detecting diabetic foot neuropathy. Acta Neurol Scand. 2005 Dec;112(6):409-13.
This publication compares the effectiveness of different screening methods in detecting diabetic foot neuropathy. The results are inconclusive in determining the optimal screening method, so further research is deemed to be necessary.
3 Vascular Endothelial Growth Factor in Diabetic Neuropathy Quality Indicator Type: Case-control study (2 groups)
Quattrini C, Jeziorska M, Boulton AJ, Malik RA. Reduced vascular endothelial growth factor expression and intra-epidermal nerve fiber loss in human diabetic neuropathy. Diabetes Care. 2008 Jan;31(1):140-5. Epub 2007 Oct 12.
This publication examines the relationship between Vascular Endothelial Growth Factor (VEGF) and peripheral nerve integrity in diabetic patients. 53 diabetic patients and 12 non-diabetic patients underwent neurological evaluation, electrophysiology, quantitative sensory, and autonomic function testing. The results showed that progressive endothelial dysfunction, a reduction in VEGF expression, and loss of intra-epidermal nerve fibers occurs in the foot skin of diabetic patients with increasing neuropathic severity.
4 Frequency-Modulated electromagnetic neural stimulation in treatment of diabetic neuropathy Quality Indicator Type: RCT
Bosi E, Conti M, Vermigli C, Cazzetta G, Peretti E, Cordoni MC, Galimberti G, Scionti L. Effectiveness of frequency-modulated electromagnetic neural stimulation in the treatment of painful diabetic neuropathy. Diabetologia. 2005 May;48(5):817-23. Epub 2005 Apr 15.
This RCT examines the effect of Frequency-Modulated electromagnetic neural stimulation (FREMS) on diabetic neuropathy. By comparing its effects with the effects of a placebo in a randomized clinical trial with 31 total patients, it was demonstrated that FREMS decreases pain (p
5 Frequency-Modulated electromagnetic neural stimulation in treatment of diabetic neuropathy Quality Indicator Type: Cohort study (2 groups)
Bevilacqua M, Dominguez LJ, Barrella M, Barbagallo M. Induction of vascular endothelial growth factor release by transcutaneous frequency modulated neural stimulation in diabetic polyneuropathy. J Endocrinol Invest. 2007 Dec;30(11):944-7.
This publication examines the effect of FREMS in the release of vascular endothelial growth factor (VEGF). In a comparison with treatment with TENS, treatment with FREMS demonstrates a release of VEGF, which can be used to explain the increase in motor conduction velocity that is associated with FREMS treatment.
6 Neuropathy in the Diabetic Foot Quality Indicator Type: Correlation study
Boyko EJ, Ahroni JH, Stensel VL. Skin temperature in the neuropathic diabetic foot. J Diabetes Complications. 2001 Sep-Oct;15(5):260-4.
The purpose of this study was to examine the validity of the common clinical assumption that neuropathy is associated with a higher foot temperature. The results demonstrate that diabetic patients with neuropathy do not have higher foot skin temperature.

Patient-Centred Concerns: Context

Adjusting to the impact of a chronic wound may be compared to adjusting to the impact of a chronic condition, such as changes after a stroke. A diabetic foot ulcer affects mobility and all activities of daily living, requires time and effort and may be associated with an embarrassing odour. Care of a diabetic foot ulcer may take over the patient’s life and become the patient’s ‘job.’ Multiple medical appointments, transportation, financial issues, and social isolation can all affect quality of life. Patients may be very worried about wound healing and afraid of amputation, and they may feel angry or frustrated with physical limitations and uneasy with the changes in their lives.

Education of people with diabetes about their condition and its management and about the importance of appropriate foot care provides the knowledge for self-management and prevention or reduction of diabetic complications. An educational focus on solutions assists patients to regain a feeling of control in their lives, to participate in their own care and to develop self-management skills.

Evidence supports the benefits of education as part of risk reduction for people with diabetes. Education improves foot-care knowledge and behaviour. Patients with a higher risk of ulceration benefit significantly from education and regular reinforcement of learning. The risk of amputation has been demonstrated to be three times greater among patients with diabetes who received no formal diabetes education. After wound closure has been achieved, education should focus on self-monitoring and prevention.

Educational interventions should follow the principles of adult learning. Education should therefore be interactive and evidence based. The learner’s experiences and needs should form the basis of the education, and the focus of the education should be developing solutions, tailored to individual abilities. Psychosocial, socioeconomic and cultural differences between patients should be considered when designing education.

Address patient-centered Concerns Level of Evidence
1 Provide patient-focused education about diabetes and its management to all patients at risk of diabetic foot ulcer to reduce the risk of diabetic foot complications. Not Assessed
2 Document pain and treat as required. Not Assessed
3 Provide education that empowers patients and encourages self management. Not Assessed
4 Follow principles of adult education in designing educational interventions: interactive; based on individual experience, needs and abilities; and focused on developing solutions. Not Assessed
5 Reinforce education regularly. Not Assessed

Essential Publications

1 Quality of Life for Patients with Diabetic Foot Ulcers Quality Indicator Type: Correlation study
Goodridge D, Trepman E, Sloan J, Guse L, Strain LA, McIntyre J, Embil JM. Quality of life of adults with unhealed and healed diabetic foot ulcers. Foot Ankle Int. 2006 Apr;27(4):274-80.
This publication reviews the literature and presents a detailed analysis of the effect of diabetic foot ulcers on quality of life. It outlines the importance of preserving quality of life through effective treatment of diabetic foot ulcers.
2 Quality of Life for Patients with Diabetic Foot Ulcers Quality Indicator Type: Prospective Correlation study
Ribu L, Hanestad BR, Moum T, Birkeland K, Rustoen T. Health-related quality of life among patients with diabetes and foot ulcers: association with demographic and clinical characteristics. J Diabetes Complications. 2007 Jul-Aug;21(4):227-36.
This publication examines the impact of diabetic foot ulcers on Health-Related Quality of Life (HRQoL). The results demonstrated that patients with healed ulcers had a greater HRQoL than patients with persisting ulcers, demonstrating the importance of effective foot ulcer care.
3 Evaluating Patient-Centered Outcomes in Diabetic Foot Ulcer Treatment Quality Indicator Type: Longitudinal study (1 group)
Jeffcoate WJ, Chipchase SY, Ince P, Game FL. Assessing the outcome of the management of diabetic foot ulcers using ulcer-related and person-related measures. Diabetes Care. 2006 Aug;29(8):1784-7.
This study is unique in that it measures treatment through both ulcer-related outcomes (size, healing rate) and patient-related outcomes (survival, amputation, being free from ulcers). The results demonstrate that ulcer-related outcomes may underestimate morbidity and mortality associated with diabetic foot ulcers, and that patient-centered concerns must be emphasized further.

Plantar Pressure Redistribution

Plantar Pressure Redistribution (Pressure Offloading)

Diabetes is associated with a variety of bony or structural foot deformities, including hammer toe, claw toe, bunions, pes planus or cavus, reduction in joint mobility and Charcot neuroarthropathy. Deformity, limited joint mobility and neuropathy result in repetitive stress on the plantar aspect of the diabetic foot during weight bearing. This mechanism predisposes to skin damage and ulceration. Redistributing plantar pressure from high-pressure areas can reduce the risk of ulceration and is a requirement for healing if ulceration has already occurred. Pressure over bony prominences may result in formation of callus, which may also increase plantar pressure. Callus removal significantly reduces pressure.

Assessment of the diabetic foot should include identification of deformities and areas of increased pressure. Gait assessment provides information about changes in balance, mobility and abnormal weight bearing that may increase the risk of falls. Examination of the patient’s footwear may reveal abnormal wear patterns. Radiography and pressure mapping may be useful in identifying deformities, determining ulcer risk or selecting an offloading device.

Effective plantar pressure redistribution uses an external device to reduce the pressure (pounds per square inch, PSI) over the wound site during weight bearing. The effectiveness of any pressure offloading device depends on patient adherence to constant use (every step taken). Appropriate patient education is therefore critical.

Selection of the appropriate downloading device is determined primarily by the ulcer location and severity. Well-fitted normal footwear; extra-depth or –width footwear plus a custom-made total contact orthotic (CMTCO) of shock-absorbing material; a rocker sole; healing sandal; removable walker; or total-contact cast (TCC) are all effective pressure downloading modalities. Crutches, walkers and wheelchairs may be ineffective due to the functional needs of patients.

The lightly padded TCC maintains contact with the entire plantar aspect of the foot and the lower leg. The effectiveness of the TCC in treating most uninfected nonischemic ulcers may result from uniform pressure distribution, protection form infection, reduction in edema and forced adherence. The lightweight removable walker is a boot that redistributes plantar pressure over the entire plantar surface of the foot. Its removable nature facilitates wound inspection and treatment but may reduce adherence. The TCC and the removable pneumatic walker are the first-choice pressure downloading devices. The Darco healing sandal can be used if problems exist with gait and balance. Healing sandals are not, however, as efficient as a TCC or a removable walker. A rocker sole, a device that can be applied to most approved extra-depth, walking or running shoes, is effective for ulcer prevention but not for healing. With the exception of the TCC, these devices are all used with a CMTCO.

Identify and Treat the Cause Level of Evidence
1 Perform a physical examination of the foot to identify structural deformity, decreased joint mobility, callus and areas of increased pressure. Not Assessed
2 Examine the patient’s gait for abnormal patterns and risk of falls. Not Assessed
3 Examine the patient’s footwear for areas of pressure and suitability. Not Assessed
4 Perform radiography and pressure mapping as required to determine risk of ulceration and pressure offloading modality selection. Not Assessed
Address patient-centered Concerns Level of Evidence
5 Provide individualized education to enhance Glycemic control, Adherence to treatment, Plantar pressure redistribution/daily foot inspection. (GAP) Not Assessed
6 Provide appropriate patient education to improve adherence and facilitate wound healing. Not Assessed
Provide Local Wound Care Level of Evidence
7 Provide plantar pressure redistribution if there is loss of protective sensation (shoes, orthotics/pneumatic walker, contact cast) Not Assessed
8 Select and implement an effective pressure offloading device, depending on the clinical goal. Not Assessed
Provide Organizational Support Level of Evidence
9 Establish and empower an interprofessional team to work with Persons With Diabetes (PWD). Not Assessed

Essential Publications

1 Pressure relieving devices to protect or treat the foot of persons with diabetes Quality Indicator Type: Systematic review
Spencer S. Pressure relieving interventions for preventing and treating diabetic foot ulcers. Cochrane Database of Systematic Reviews 2000, Issue 3. Art. No.: CD002302. DOI: 10.1002/14651858.CD002302.
This good quality Cochrane systematic review (2000) was conducted to assess the effectiveness of pressure relieving interventions in the prevention and treatment of diabetic foot ulcers; it is the only systematic review on this topic. The 4 included RCTs had small sample sizes, methodological flaws (e.g., lack of blinding, alternate rather than random allocation, no a priori sample size determination), and the data could not be combined due differences in patients, interventions and outcomes. The results provided little evidence of the effectiveness of orthotic devices or therapeutic shoes for preventing foot ulcers. One RCT (Mueller, 1989) indicates limited evidence in subjects with diabetic foot ulcers of the effectiveness of total contact casts compared with standard treatment (wet to dry dressings only) for improving healing rates (proportion of subjects healed) and time to healing. This review illustrates gaps and provides recommendations about directions and methodological issues to incorporate for future research about the value of pressure relieving and off-loading interventions for the prevention and treatment of diabetic foot ulcers.
2 Total contact casting Quality Indicator Type: RCT
Piaggesi A, Macchiarini S, Rizzo L, Palumbo F Tedischi A, Nobili LA, Leporati E, Scire V, Teobaldi I, Del Prato S. An off-the-shelf instant contact casting device for the management of diabetic foot ulcers. A randomized prospective trial versus traditional fiberglass cast. Diabetes Care 2007;30(3):586-90.
This recent comparison of total contact casting (nonremovable fiberglass cast), n=20) with an off-the-shelf irremovable device (Optima Diab walker, n=20) was performed in outpatients with forefoot plantar ulcers for at least 3 weeks with an area wider than 1 cm2, graded 1A or 2A (Texas University classification), and type 1 or type 2 diabetes for at least 5 years, with peripheral neuropathy. Healing rate (proportion of subjects with complete reepithelialization) and time to heal were not significantly different between the groups, but the cost per patient (727.29 + 491.25 versus 162.5 + 57.75 euros) of the Optima Diab walker was significantly less (P
3 Total contact casting versus removable casting Quality Indicator Type: RCT
Armstrong DG, Lavery LA, Wu S, Boulton AJM. Evaluation of Removable and Irremovable Cast Walkers in the Healing of Diabetic Foot Wounds: A randomized controlled trial. Diabetes Care 2005;28(3):551-554.
In this study the use of a removable cast walker (RCW) n=27 was compared with the same RCW wrapped with cohesive bandage to create an “instant total contact cast” (iTCC) n=23 to determine if less success with RCW was due to patients’ lack of adherence with the pressure relieving regimen in patients with foot ulcers and diabetic neuropathy who were treated for 12 weeks or until healing. It was found that a higher proportion of patients’ ulcers healed at 12 weeks in the iTCC group than in the RCW group (82.6 vs. 51.9%, P=0.02; OR 1.8 (95% CI 1.1-2.9)). Patients with healed ulcers that healed who were treated with an iTCC healed significantly more quickly (41.6 ± 18.7 versus 58.0 ± 15.2 days, P=0.02). There is a trade-off between healing and periwound maceration, as experienced by more subjects in the iTCC group compared with the RCW group (68.2% or 15 patients versus 37.5% or 9 patients, P=0.04; OR 1.8 (95% CI 1.0-3.3)). This well-designed study seems to indicate that patient adherence with wearing a removable cast could be limiting their ability to heal and the time to healing of foot ulcers.
4 Total contact casting versus instant total contact casting Quality Indicator Type: RCT
Katz IA, Harlan A Miranda-Palma B, Prieto-Sanchez L, Armstrong DG, Bowker JH, Mizel MS, Boulton AJM. A Randomized Trial of Two Irremovable Off-Loading Devices in the Management of Plantar Neuropathic Diabetic Foot Ulcers. Diabetes Care 2005;28(3):555-559.
(Parallel study to Armstrong 2005) This study was conducted to compare the effectiveness of a removable cast walker (RCW) rendered irremovable (iTCC) with the total contact cast (TCC) in the treatment of diabetic neuropathic plantar foot ulcers. There was no difference between the TCC n=20 and iTCC n=21groups in the proportions of patients with ulcers that healed in less than or equal to 12 weeks, 74 ± 45 and 80 ± 41%, respectively (P=0.65). There was also no difference in complications with a relative risk reduction of 41% and absolute risk reduction of 27% (P=0.09) between the TCC and iTCC groups. the iTCC may be equally efficacious, faster to place, easier to use, and less expensive than the TCC in the treatment of diabetic plantar neuropathic foot ulcers.
5 Pressure off-loading – adherence to off-loading regimen Quality Indicator Type: Longitudinal study (1 group)
Armstrong DG, Lavery LA, Kimbriel HR, Nixon BP, Boulton AJM. Activity Patterns of Patients with Diabetic Foot Ulceration: Patients with active ulceration may not adhere to a standard pressure off-loading regimen. Diabetes Care 2003;26(9):2595-2597.
This study illustrates that patients do not adhere to wearing RCW during activity as often as they ought. Accelerometers were installed at patients’ waists and hidden in the RCW. It was found that patients wore the RCW less than 30% of the total activity time. It was this result that prompted the work on instant total contact casting (iTCC).
6 Pressure off-loading to prevent reulceration – comparison of footwear Quality Indicator Type: RCT
Reiber GE, Smith DG, Wallace C, Sullivan K, Hayes S, Vath C, Maciejewski ML, Yu O, Heagerty PJ, LeMaster J. Effect of Therapeutic Footwear in Foot Reulceration in Patients with Diabetes: A randomized controlled trial. JAMA 2002;287(19):2552-2558.
This well-conducted 2-year study of persons with diabetes and without severe foot deformity illustrates no advantage of prescribing therapeutic shoes and inserts for the reduction of foot reulceration. Between August 1997 and December 1998, subjects were randomly allocated to 3 groups: Groups (1) and (2) received 3 pairs of therapeutic shoes, and (1) received 3 pairs of customized medium density cork inserts with a neoprene closed-cell cover (n=121) and (2) received 3 pairs of prefabricated, tapered polyurethane inserts with a brushed nylon cover (n=119). Group (3), the control group, wore their usual footwear (n=160). Two-year cumulative reulceration incidence was 15%, 14%, and 17% for the 3 groups respectively. For the group with cork inserts compared for controls, the relative risk for persons with one or more reulcerations was RR 0.88 (95% CI 0.51to 1.52). For the group with prefabricated inserts compared for controls, the relative risk for persons with one or more reulcerations was RR 0.85 (95% CI 0.48to 1.48). People without sensation were much more likely to experience reulceration; the RR was 3.68 (95% CI 1.81 to 7.49).
7 Pressure off-loading to achieve ulcer healing Quality Indicator Type: RCT
Armstrong DG, Nguyen HC, Lavery LA, van Schie CHM, Boulton AJM, Harkless LB. Off-Loading the Diabetic Foot Wound: A randomized clinical trial. Diabetes Care 2001;24(6):1019-1022.
This is a small, randomized trial comparing the proportion of healed ulcers in subjects treated using TCC (n=10) compared with removable cast walker (RCW) (n=20), and half shoes (n=24). More ulcers healed with TCC 80.5% than with RCW 65% or half-shoes 58.3%. At 12 weeks, the proportion of healing was significantly greater in the TCC group than with the other modalities (89.5% vs. 61.4%, P=0.026, odds ratio 5.4, 95% CI 1.1 to 26.1). The mean time to healing was shorter for those using TCC compared with half-shoes (33.5 + 5.9 vs. 61.0 + 6.5 days, P = 0.005) but not compared with RCW (50.4 + 7.2 days, P=0.07). The discussion of the following advantages and disadvantages of TCC is helpful in planning appropriate treatment options: advantages include mitigating pressure, controlling edema, protecting from infection, forcing compliance, and curtailing activity; disadvantages include lack of trained personnel to apply TCC, potential skin irritation with improper application, inability to make daily assessments or treatments, difficulty bathing and sleeping; contraindicated for wounds with infections of osteomyelitis.
8 TCC Versus other off-loading devices Quality Indicator Type: Non-randomized controlled trial
Udovichenko O, Galstyan G. Efficacy of Removable Casts in Difficult to Off-Load Diabetic Foot Ulcers: A comparative study. The Diabetic Foot 2006;9(4):204-208.
TCC for those who accepted n=14 and alternative off-load methods (half-shoe or bed rest) for those who refused n=13. Larger wounds were observed in the TCC group at baseline (Wound equivalent radius (Reqv in mm) 13.3 + 3.1 versus 6.7 + 1.4, P
9 Comparison of TCC with traditional dressing treatment Quality Indicator Type: RCT
Mueller MJ. Diamond JE. Sinacore DR. Delitto A. Blair VP 3rd. Drury DA. Rose SJ. Total contact casting in treatment of diabetic plantar ulcers. Controlled clinical trial. Diabetes Care 1989;12(6):384-8.
This study indicates benefits and disadvantages of Total Contact Casting (TCC). It is one of the included studies in the Registered Nurses Association of Ontario (RNAO)Assessment and management of foot ulcers for people with diabetes guideline (2005). This article may be the earliest best article on this topic.
10 Comparison of foot pressures in different types of pressure relieving foot devices Quality Indicator Type: Non-randomized controlled trial
Lavery LA, Vela SA, Lavery DC, Quebedeaux TL. Reducing dynamic foot pressures in high-risk diabetic subjects with foot ulcer … Diabetes Care 1996;19(8):818-821.
This study compares the ability of TCC, DH pressure relief walkers, Aircast pneumatic walker, 3D Dura Steppers, CAM Walkers, P.W. Minor Xtra Depth shoes commercially available therapeutic shoes to reduce mean peak plantar foot pressures over neuropathic ulcers under the great toe (n=5), the first metatarsal (n=10), and the 2nd to 5th metatarsal (n=10) in people with diabetes. Pressures experienced using six devices were compared with those obtained using a rubber-soled canvas Oxford. DH removable walker was as effective as TCC in reducing foot pressures at all ulcer sites. This seems to be the key article that establishes the ability of various devices to reduce foot pressure over ulcer sites.
11 Pressure Relief through Custom Insoles Quality Indicator Type: Cohort study (2 groups)
Owings TM, Woerner JL, Frampton JD, Cavanagh PR, Botek G. Custom therapeutic insoles based on both foot shape and plantar pressure measurement provide enhanced pressure relief. Diabetes Care. 2008 May;31(5):839-44. Epub 2008 Feb 5.
The purpose of this study was to determine whether custom insoles designed based on the shape and pressure distribution of the patient’s foot are effective in removing plantar pressure. 20 patients with 70 areas of elevated pressure were provided with pressure relieving insoles, and the pressure concentration was alleviated in 64 of 70 cases. These results show that measurement of plantar pressure in designing custom insoles is effective at pressure offloading in patients with elevated plantar pressure.
12 Neuropathy and High Foot Pressures Quality Indicator Type: Prospective Correlation study
Frykberg RG, Lavery LA, Pham H, Harvey C, Harkless L, Veves A. Role of neuropathy and high foot pressures in diabetic foot ulceration. Diabetes Care. 1998 Oct;21(10):1714-9.
The purpose of this study was to investigate the role of neuropathy and high foot pressure in the development of diabetic foot ulcers. One significant benefit of this study is the size and diversity of the population. The results demonstrate that both neuropathy and high foot pressure are associated with diabetic foot ulceration. Furthermore, joint mobility and plantar pressure have greater correlation with ulceration in Caucasian populations than in African-American or Hispanic populations.
13 Peak foot pressure during walking Quality Indicator Type: Correlation study
Morag E, Cavanagh PR. Structural and functional predictors of regional peak pressures under the foot during walking. J Biomech. 1999 Apr;32(4):359-70.
The purpose of this study was to examine structural and functional factors which are predictors of peak pressure during walking. This study is able to successfully identify etiology behind elevated plantar pressure, and also proposes important areas for future research
14 Foot Pressure Assessment Quality Indicator Type: Longitudinal study (1 group)
Lavery LA, Armstrong DG, Wunderlich RP, Tredwell J, Boulton AJ. Predictive value of foot pressure assessment as part of a population-based diabetes disease management program. Diabetes Care. 2003 Apr;26(4):1069-73.
The purpose of this study is to evaluate the ability of plantar pressure assessment to predict patients at high risk of ulceration. The results showed that elevated pressure is effective in determining patients at risk for foot ulcerations. These results, however, contradict the results obtained by ROC analysis.
15 Alternative off-loading methods Quality Indicator Type: Retrospective Analysis
Birke JA, Pavich MA, Patout Jr CA, Horswell R. Comparison of forefoot ulcer healing using alternative off-loading methods in patients with diabetes mellitus. Adv Skin Wound Care. 2002 Sep-Oct;15(5):210-5.
The purpose of this study was to compare alternative off-loading methods (an accommodative dressing, a healing shoe, a walking splint) with total contact casts. The results showed that both methods provide comparable results when the treatment strategy is selected based on the patients age, and duration and location of the ulcer.
16 Football dressing for off-loading Quality Indicator Type: Retrospective Analysis
Rader AJ, Barry TP. The football: an intuitive dressing for offloading neuropathic plantar forefoot ulcerations. Int Wound J. 2008 Mar;5(1):69-73. Epub 2008 Jan 3.
The purpose of this study was to follow up on a pilot study regarding a new dressing known as the football dressing. This follow up study showed that the football dressing is easy to apply, presents reliable healing rates and is inexpensive. All of these benefits make the football dressing a legitimate dressing for offloading neuropathic plantar forefoot ulcerations.
17 Ankle Equinus Quality Indicator Type: Prevalence study
Lavery LA, Armstrong DG, Boulton AJ; Diabetex Research Group. Ankle equinus deformity and its relationship to high plantar pressure in a large population with diabetes mellitus. J Am Podiatr Med Assoc. 2002 Oct;92(9):479-82
The purpose of this study is to determine the prevalence of ankle equinus, and to determine its relationship with high plantar pressure. The results showed that patients who have had diabetes for longer periods of time were more likely to develop ankle equinus. In order to prevent amputation, it is essential to have a high index of suspicion for this condition, then to address it appropriately

Pressure Redistribution - Role of Surgery

The various bony or structural foot deformities seen in patients with diabetes may result in abnormally increased pressure in specific areas, especially on the plantar surface of the foot. These deformities include hammer toe, claw toe, bunions, pes planus or cavus, reduction in joint mobility and Charcot neuroarthropathy. Pressure downloading devices are commonly used to redistribute this pressure, prevent or treat foot ulcers and prevent amputation. Ulceration, infection and amputation are diabetic foot complications that often result in extensive morbidity, frequent hospitalization and mortality. These complications are also associated with significant costs. An analysis of healthcare costs of diabetic neuropathy in the United States found that the mean annual cost of treating an uninfected ulcer was $9,306, whereas the cost of treating an infected ulcer with osteomyelitis was greater than $45,000.

Appropriate management and prevention strategies have the potential to substantially reduce the incidence of diabetic foot complications. Prophylactic surgical correction of tendon, bone or joint deformity in diabetic patients with neuropathy redistributes increased pressure and may reduce the risk of ulceration. In patients with ineffective pressure downloading, surgical correction of foot deformity may prevent ulcer recurrence.

Surgical pressure redistribution in patients with uninfected ulcer may be an important part of the treatment strategy, and effective surgical management of acute Charcot joint may prevent further foot damage. For patients with an infected limb-threatening ulcer, resection of infected bone or joints in conjunction with procedures to remove areas of chronically increased pressure may be an alternative to partial foot amputation. Skin grafting may also be combined with correction of deformity to speed healing. The presence of critical ischemia should prompt referral for possible revascularization surgery prior to deformity correction.

After surgical correction of foot deformity, appropriate foot care should be implemented according to risk category.

Identify and Treat the Cause Level of Evidence
1 Take a careful history (general history, diabetic control and complications). Not Assessed
2 Conduct a foot inspection and examine for decreased sensation. Correct (if possible) risk factors for ulcer formation/amputation:§ Vascular supply§ Infection§ Pressure (including bony deformity)Remember the mnemonic VIP Not Assessed
Address patient-centered Concerns Level of Evidence
3 Provide individualized education to enhance Glycemic control, Adherence to treatment, Plantar pressure redistribution/daily foot inspection. (GAP) Not Assessed
Provide Local Wound Care Level of Evidence
4 Consider prophylactic deformity correction in diabetic patients with neuropathy to prevent ulceration, especially if use of pressure downloading devices has been ineffective. Not Assessed
5 Consider surgical pressure redistribution in patients with acute Charcot joint to prevent further injury and ensure a stable foot. Not Assessed
6 Consider surgical correction of foot deformity in patients with acute ulcer to speed healing. Not Assessed
7 In patients with an infected ulcer, consider resection of infected bone or joints in conjunction with surgical correction of foot deformity as an alternative to partial foot amputation. Not Assessed
Provide Organizational Support Level of Evidence
8 Establish and empower an interprofessional team to work with Persons With Diabetes (PWD). Not Assessed

Essential Publications

1 Achilles Tendon Lengthening to heal plantar ulcers Quality Indicator Type: RCT
Mueller MJ, Sinacore DR, Hastings MK, Strube MJ, Johnson JE. Effect of Achilles Tendon Lengthening on Neuropathic Plantar Ulcers: A randomized clinical trial. The Journal of Bone and Joint Surgery 2003;85A (8):1436-1445.
This study compared the healing of diabetic neuropathic ulcers of the forefoot and limited ankle dorsiflexion (less than or equal to 5 degrees) with TCC plus or minus Achilles tendon lengthening. Healing times were similar but recurrences were reduced with Achilles tendon lengthening.
2 Achilles Tendon Lengthening – ankle muscle performance Quality Indicator Type: RCT
Salsich et al. Effect of Achilles Tendon Lengthening on Ankle Muscle Performance in People With Diabetes Mellitus and a Neuropathic Plantar Ulcer. Physical Therapy 2005; 85(1): 34-43.
This is the first study of the effect of tendo-Archilles lengthening (TAL) on active and passive muscle performance in subjects with diabetes mellitus and a neuropathic plantar ulcer. (This is part of the Mueller et al, 2003 stduy.) The effects of TAL plus total-contact casting (TCC) (n=15) were compared with TCC alone (n=14) on ankle muscle performance (isokinetic dynamometer). Following surgery, subjects in the TAL group experienced 31% decrease in concentric plantar-flexion peak torque (initial 35±3 to pretest 24±3 N.m, P < 0.05); 64% reduction in passive torque at 0 degrees of dorsiflexion (initial posttest 18±2 to pretest 6±2 N.m, P < 0.05). Following TAL surgery, the angle of concentric plantar-flexor peak torque moved 16 degrees into dorsiflexion, comparing initial posttest with pretest (P< 0.05). There were no differences in dorsiflexion peak torque across groups or time. TAL led to a temporary decrease in active and passive plantar-flexor muscle performance. Since plantar flexor musculature is compromised following surgery, attention must be paid to the risk of plantar ulcer recurrence.
3 Surgical versus non-surgical approach for diabetic neuropathic foot ulcers Quality Indicator Type: RCT
Piaggesi A, Schipani E, Campi F, Romanelli M, Baccetti F, Arvia C, Navalesi R. Conservative Surgical Approach Versus Non-surgical Management for Diabetic Neuropathic Foot Ulcers: a Randomized Trial. Diabetic Medicine 1998;15:412-417.
This study was the first to compare surgical treatment (n=21) with non-surgical care i.e., weight-bearing pressure relief and regular dressings (n=20), in patients with diabetic neuropathic foot ulcers. Healing rate for the non-surgical group was less at 79% than for the surgical group (P < 0.05). Healing time was less for the surgical than the non-surgical group 46.73 + 38.94 vs. 128.91 + 86.60 days respectively. More infection was seen in the non-surgical group but the surgical group was treated with antibiotics for 5 days according to regular protocol. Recurrence rate was less for the surgical group, 14% vs. 41% (P < 0.01). Patient satisfaction and discomfort favoured the surgical group. This small study suggests that surgical intervention that involves excision of the ulcer, debridement or removal of involved bone, and suturing of the wound margins, is an effective treatment option.
4 Joint arthroplasty Quality Indicator Type: Case-control study (2 groups)
Armstrong DG, Lavery LA, Vazquez JR, Short B, Kimbriel HR, Nixon BP, Boulton AJ. Clinical efficacy of the first metatarsophalangeal joint arthroplasty as a curative procedure for hallux interphalangeal joint wounds in patients with diabetes. Diabetes Care. 2003 Dec;26(12):3284-7.
The purpose of this study is to evaluate the effectiveness and safety of first metatarsophalangeal joint arthroplasty versus conventional non-surgical management of wounds in patients with diabetes. This was achieved by assigning a surgical and a non-surgical group, and comparing time to healing, amputation, reulceration and infection. The results showed that the surgical group experienced favourable outcomes in all four of the aforementioned categories, indicating that joint arthroplasty is a safe and effective option that can be implemented clinically.
5 Surgical treatment of diabetic foot wounds Quality Indicator Type: Narrative Review
Strauss MB. Surgical treatment of problem foot wounds in patients with diabetes. Clin Orthop Relat Res. 2005 Oct;439:91-6.
This article acts as a summary on surgical treatment of diabetic foot wounds. The publication discusses both diagnosis and surgical treatment of diabetic foot wounds.
6 Classification of diabetic foot surgery Quality Indicator Type: Scale Description
Armstrong DG, Frykberg RG. Classifying diabetic foot surgery: toward a rational definition. Diabet Med. 2003 Apr;20(4):329-31.
This publication describes a method of classifying diabetic foot surgery based on the presence or absence of neuropathy, open wounds and acute, limb-threatening infection. Based on these factors, a four-level classification is presented: elective, prophylactic, curative and emergent. This publication is useful because this classification can be implemented clinically to help facilitate communication among physicians.
7 Surgical versus non-surgical treatment of diabetic foot ulcers Quality Indicator Type: RCT
Piaggesi A, Schipani E, Campi F, Romanelli M, Baccetti F, Arvia C, Navalesi R. Conservative surgical approach versus non-surgical management for diabetic neuropathic foot ulcers: a randomized trial. Diabet Med. 1998 May;15(5):412-7.
This publication compares surgical versus non-surgical treatment in the management of diabetic, neuropathic foot ulcers. The results show that, based on complications, relapses and healing time, conservative surgical treatment is beneficial and can be safely and effectively used in outpatient settings.

Prevention

A preventive approach can be applied to all patients at risk of diabetic foot ulcer or amputation, from patients with no current pathology and no history of ulceration to those who have ulcer, infection and ischemia. To determine appropriate preventive strategies, the clinician must first determine a risk category.

For patients in all categories, addressing co morbidities and systemic factors such as achieving or maintaining glycemic control is a key preventive strategy. Hyperglycemia is a major factor in the development and progression of microvascular complications, such as neuropathy, which are strongly linked to diabetic foot ulcers. Optimal management of vascular risk factors, such as hypertension and dyslipidemia is also recommended. Risk factor reduction can help to slow progression of atherosclerosis, peripheral arterial disease and vascular insufficiency, which also contribute to the development of diabetic foot ulcers. Patients who have ischemia of the limb require a vascular surgery consultation, as revascularization may be necessary. Effective patient education, encompassing glycemic control, risk factor management and foot care, is an important preventive strategy.

Patients who have bony or structural deformities of the foot and those who have neuropathy require regular assessment and possible shoe accommodation to prevent irritation or excessive pressure, which predisposes to ulceration. For patients with Charcot joint, thermometric and radiographic monitoring is indicated. Patients with both neuropathy and deformity may require more frequent assessment. They may also benefit from custom molded or extra deep shoe accommodation or from prophylactic surgery to correct the bony deformity of concern. If a history of ulceration is also present, custom shoe accommodation to prevent recurrence is recommended, along with consideration of prophylactic surgery to correct bony deformities.

Identify and Treat the Cause Level of Evidence
1 Take a careful history (general history, diabetic control and complications). Not Assessed
2 Perform a foot examination at least annually in all people with diabetes over the age of 15 and at more frequent intervals for those at higher risk. Not Assessed
3 Determine risk category for all patients with a risk of diabetic ulcer or amputation. Not Assessed
4 Advise individuals at higher risk for foot ulcer/amputation of their risk status and refer them to their primary care provider, specialized diabetes or foot care treatment for additional assessment as appropriate. Not Assessed
5 Manage existing ulcers appropriately and treat infection aggressively. Not Assessed
6 Correct (if possible) risk factors for ulcer formation /amputation: ♦ Vascular supply ♦ Infection ♦ Pressure (including bony deformity) Remember the patient assessment / treatment mnemonic VIP Not Assessed
Address Patient-Centered Concerns Level of Evidence
7 Provide individualized education to enhance Glycemic control, Adherence to treatment, Plantar pressure redistribution/daily foot inspection. Remember the patient education mnemonic GAP Not Assessed
Provide Local Wound Care Level of Evidence
8 Institute appropriate local preventive strategies, including monitoring of pressure associated with bony deformities and use of appropriate accommodative footwear. Not Assessed
9 Obtain a vascular consultation for patients with limb ischemia and consider revascularization surgery. Not Assessed
10 Consider prophylactic surgery to correct bony deformities. Not Assessed
Provide Organizational Support Level of Evidence
11 Establish and empower an interprofessional team to work with Persons With Diabetes (PWD). Not Assessed
12 Advocate for strategies and funding to assist patients in obtaining appropriate pressure redistribution devices Not Assessed

Essential Publications

2 Prevention of foot ulcers Quality Indicator Type: Systematic review
Singh N, Armstrong DG, Lipsky BA. Preventing foot ulcers in patients with diabetes. JAMA. 2005 Jan 12;293(2):217-28.
This systematic review of RCTs, case control studies and cohort studies was conducted to review the efficacy of methods recommended for preventing diabetic foot ulcers in the primary care setting. This review provides evidence that supports screening all patients with diabetes for risk for foot ulceration so that they might receive appropriate preventive interventions.
3 Prevention of foot ulcer Quality Indicator Type: RCT
Lavery LA, Higgins KR, Lanctot DR, Constantinides GP, Zamorano RG, Athanasiou KA, Armstrong DG, Agrawal CM. Preventing diabetic foot ulcer recurrence in high-risk patients: Use of temperature monitoring as a self-assessment tool. Diabetes Care 2007;30(1):14-20.
Patient self-monitoring of temperature to reduce the incidence of foot ulcers was evaluated in patients with diabetes and previous history of ulcers. Three interventions were compared: (I) standard therapy (n=58), (2) structured foot examination (n=56), and (3) enhanced therapy using an infrared skin thermometer (n=59). By notifying the study nurse and reducing activity if there was a temperature difference of more than 4oF (2.2oC) between left and right corresponding sites, the incidence of foot ulcers was significantly reduced. Incidence of foot ulcers in enhanced therapy group 8.5%, standard therapy group 29.3%(P=0.0046), and structured foot exam group 30.4% (P=0.0029). Patient infrared thermometer monitoring decreases the incidence of foot ulcers.
4 Prediction and prevention of foot ulcers Quality Indicator Type: Prospective Correlation study
Boyko EJ, Ahroni JH, Cohen V, Nelson KM, Heagerty PJ. Prediction of Diabetic Foot Ulcer Occurrence Using Commonly Available Clinical Information: The Seattle Diabetic Foot Study. Diabetes Care, June 1, 2006; 29(6): 1202 – 1207.
In this large prospective study, 1285 diabetic veterans without foot ulcers were evaluated to determine risk associated with clinical and laboratory information. A1C, impaired vision, prior foot ulcer, prior amputation monofilament insensitivity, tinea pedis and onychomycosis all are predictors for diabetic foot ulcers. Knowing these risk factors can help clinicians predict, and therefore prevent, the occurrence of diabetic foot ulcers.
5 Prevention of amputation Quality Indicator Type: Retrospective Analysis
Markowitz JS, Gutterman EM, Magee G, Margolis DJ. Risk of amputation in patients with diabetic foot ulcers: a claims-based study. Wound Rep Reg 2006;14:11-17.
In a retrospective analysis of claims data of diabetic foot ulcer patients with amputations were matched on follow-up days with non-amputated control subjects to determine risk factors for amputation. For 5911 eligible patients, the incidence density rate was 2.3 amputations per 100 person years (95% Confidence Interval 1.91-2.77). The significant risk factors (adjusted odds ratio) were male gender (1.98), Charlson co-morbidity score of 4-5 (2.89) or 6+ (5.36), renal disease (2.11), PVD (2.67), and 5+ out patient DFU services (2.17). Awareness of the risk factors associated with amputation may prompt clinicians to adopt a more aggressive approach to the care of patients with DFU.
6 Prevention of primary major amputation – determination of risk factors Quality Indicator Type: Retrospective Analysis
Dos Santos VP, da Silveira DR, Caffaro RA. Risk factors for primary major amputation in diabetic patients. Sao Paulo Med J 2006;124(2):66-70.
Patients in this retrospective analysis underwent major amputation (n=48) or minor amputation/debridement (n=51). Although numerous variables were investigated, ascending lymphangitis was seen significantly more often in patients with major versus amputation (88.2% versus 75%, χ2 = 3.86 P = 0.???); the probability of supra or infrapatellar amputation was 2.5 times greater than when it was absent. It is important to know the risk factors for amputation and to modify them if possible.
7 Prevention of major amputation in foot with gangree – determination of risk factors Quality Indicator Type: Retrospective Analysis
Miyajima S, Shirai A, Yamamoto S, Okada N, Matsushita T. Risk factors for major limb amputation in diabetic foot gangrene patients. Diabetes Research and Clinical Practice 2006;71:272-279.
In this retrospective analysis of 210 patients, independent risk factors for major limb amputations were arteriosclerosis obliterans, hemodialysis, and HbA1c.
8 Topical antifungal nail lacquer Quality Indicator Type: RCT
Armstrong DG, Holtz K, We S. Can the use of a topical antifungal nail lacquer reduce risk for diabetic foot ulceration? Results from a randomized controlled pilot study. International Wound Journal 2005;2(2):166-170.
In this randomized controlled pilot study to compare daily self-inspection with and without the use of a topical antifungal nail lacquer, the proportion of persons with ulceration were very similar and no significant difference was found. There was however an unexpected and interesting secondary finding of significantly lower proportion of patients with hyperkeratosis or tinea pedis.
9 Patient education for prevention Quality Indicator Type: Systematic review
Valk GD, Kriegsman DMW, Assendelft WJJ. Patient education for preventing diabetic foot ulceration. Cochrane Database of Systematic Reviews 2001, Issue 4. Art. No.: CD001488. DOI: 10.1002/14651858.CD001488.pub2.
Although the methodological quality of the RCTs in this systematic review was poor and the results were conflicting, there is weak evidence that educational interventions in high-risk patients reduced the incidence of foot ulceration and amputation.
10 Prediction of foot ulcers Quality Indicator Type: Systematic review
Crawford F, Inkster M, Kleijnen J and Fahey T. Predicting foot ulcers in patients with diabetes: a systematic review and meta-analysis. Q J Med 2007; 100:65–86.
This well-designed systematic review of case-control and cohort studies, with incidence of foot ulcers from 8% to 17%, indicated the predictive value of diagnostic tests of peripheral neuropathy and plantar pressure for diabetic foot ulceration. The predictive value of signs and symptoms has not been established.
11 Risk Factors for Diabetic Foot Complications Quality Indicator Type: Prevalence study
Lavery LA, Peters EJ, Williams JR, Murdoch DP, Hudson A, Lavery DC; International Working Group on the Diabetic Foot. Reevaluating the way we classify the diabetic foot: restructuring the diabetic foot risk classification system of the International Working Group on the Diabetic Foot. Diabetes Care. 2008 Jan;31(1):154-6. Epub 2007 Oct 12.
Following its analysis, this publication presents a modified version of the IWGDF classification system for diabetic feet, known as the Texas Classification System, which the publication shows is more effective than the original classification system.
12 Risk factors for Amputation Quality Indicator Type: Prospective Correlation study
Adler AI, Boyko EJ, Ahroni JH, Smith DG. Lower-extremity amputation in diabetes. The independent effects of peripheral vascular disease, sensory neuropathy, and foot ulcers. Diabetes Care. 1999 Jul;22(7):1029-35.
This study examines potential risk factors for lower-extremity amputation. Through a prospective study, it identifies the following independent risk factors for amputation in patients with diabetes: peripheral sensory neuropathy, peripheral vascular disease, foot ulcers, previous amputation and treatment with insulin.
13 Incidence of ulceration and amputation Quality Indicator Type: Longitudinal study (1 group)
Armstrong DG, Harkless LB. Outcomes of preventative care in a diabetic foot specialty clinic. J Foot Ankle Surg. 1998 Nov-Dec;37(6):460-6.
The study’s purpose was to examine the incidence of ulceration and amputation in diabetic patients treated in a multidisciplinary clinic. The results demonstrated that a multidisciplinary approach and risk-based treatment are extremely beneficial in preventing and managing foot ulcers in diabetic patients.
14 Foot problems in patients on hemodialysis Quality Indicator Type: Prevalence study
Locking-Cusolito H, Harwood L, Wilson B, Burgess K, Elliot M, Gallo K, Ische J, Lawrence-Murphy JA, Ridley J, Robb M, Taylor C, Tigert J. Prevalence of risk factors predisposing to foot problems in patients on hemodialysis. Nephrol Nurs J. 2005 Jul-Aug;32(4):373-84.
The purpose of this study is to identify the prevalence of risk factors that predispose patients on hemodialysis to increased risk of foot ulceration. The results show that patients on hemodialysis are at increased risk for foot ulceration, and that nursing management should include foot assessment, patient education, and referral to foot specialists when necessary
15 Temperature Monitoring Quality Indicator Type: RCT
Armstrong DG, Holtz-Neiderer K, Wendel C, Mohler MJ, Kimbriel HR, Lavery LA. Skin temperature monitoring reduces the risk for diabetic foot ulceration in high-risk patients. Am J Med. 2007 Dec;120(12):1042-6.
The purpose of this study was to evaluate the clinical effectiveness of at-home temperature monitoring in the prevention of diabetic foot ulceration. The results show that if patients are provided sufficient education, at-home temperature monitoring can be an effective tool in preventing diabetic foot ulceration.
16 Temperature Monitoring Quality Indicator Type: Narrative Review
Lavery LA, Armstrong DG. Temperature monitoring to assess, predict, and prevent diabetic foot complications. Curr Diab Rep. 2007 Dec;7(6):416-9.
The purpose of this study is to review the literature examining the effect of home temperature monitoring on the onset of diabetic foot complications. The results show that using home temperature monitoring as a risk assessment tool can decreases ulceration by anywhere between 3 times and 10 times in high-risk patients.

Review of Classification Systems

Classification systems have been developed to assist the clinician in gathering the appropriate information to stratify diabetic patients into risk categories. These systems are useful in promoting a consistent approach to clinical examination and in providing a common language to facilitate communication between the multiple specialties often involved in caring for a diabetic patient.

The University of Texas Diabetic Foot Classification System divides the diabetic foot into the following categories:

0: No pathology 1: Neuropathy, no deformity 2: Neuropathy with deformity 3: History of pathology 4A: Neuropathic wound 4B: Acute Charcot’s joint 5: Infected diabetic foot 6: Ischemic limb

Diabetic feet falling into categories 0–3 are at risk of ulceration, whereas diabetic feet with ulcers (categories 4–6) are at risk of amputation. History and the results of physical examination and specific investigations determine category. Each category is associated with a recommended frequency of monitoring or assessment, implementation of preventive strategies and medical and/or surgical treatment approaches.

The International Working Group on the Diabetic Foot Risk Classification System uses a simple four-point risk classification system associated with a recommended evaluation frequency:

0: Normal Annual 1: Peripheral neuropathy, with loss of protective sensation Semi-annual 2: Neuropathy, deformity and/or peripheral arterial disease Quarterly 3: Previous ulcer or amputation Monthly to quarterly

The Carville system classifies diabetic feet into the following risk categories and provides recommendations for appropriate footwear to prevent ulceration:

0: No loss of protective sensation. 1: Loss of protective sensation, no deformity or history of plantar ulceration 2: Loss of protective sensation and deformity, no history of plantar ulceration 3: History of plantar ulcer.

The Wagner Classification grades diabetic ulcers to assist with planning treatment, as follows: 1: Superficial ulcer with partial- or full-thickness skin loss 2: Probing to tendon or capsule with soft-tissue infection 3: Deep ulcer with osteomyelitis 4: Ulcer with forefoot gangrene 5: Ulcer with gangrene involving entire foot

Identify and Treat the Cause Level of Evidence
1 Conduct a foot inspection and examine for decreased sensation. Correct (if possible) risk factors for ulcer formation/amputation: – Vascular supply – Infection – Pressure (including bony deformity) Remember the mnemonic VIP Not Assessed
2 Assess and document healing with ulcer duration, location, size, and depth (probe to bone). Not Assessed
Address patient-centered Concerns
n/a
Provide Local Wound Care Level of Evidence
3 Assess and document healing with ulcer duration, location, size, and depth (probe to bone). Not Assessed
4 Integrate the risk classification system into clinical protocols so that it is consistently applied. Not Assessed
Provide Organizational Support Level of Evidence
5 Each clinic providing diabetic foot care should review the diabetic foot risk classification systems and select the one that best meets the needs of the population served. Not Assessed

Essential Publications

1 University of Texas Diabetic Wound Classification System Quality Indicator Type: Scale Description
Lavery LA, Armstrong DG, Harkless LB. Classification of diabetic foot wounds. J Foot Ankle Surg 1996;35:528-531
This well-known classification system for diabetic foot infections developed to guide future surgical treatment protocols, algorithms. The classification system grades depth, ischaemia and infection.
2 University of Texas Diabetic Wound Classification System – validation Quality Indicator Type: Retrospective Analysis
Armstrong DG, Lavery LA, Harkless LB. Validation of a diabetic wound classification system. Diabetes care 1998;21(5):855-858.
Validation of the University of Texas grading system based on retrospective analysis of medical records of 360 diabetic patients in multidisciplinary tertiary care diabetic foot clinic, illustrating that outcomes deteriorate with increasing grade and stage of wounds.
3 Wagner Grading System for the Dysvascular Foot Quality Indicator Type: Retrospective Analysis
Wagner FW. The Dysvascular Foot: A system for diagnosis and treatment. Foot & Ankle 1981;2(2):64-122.
This is the well-known Wagner foot grading system, devised by Dr. Wagner many years ago, through observing progression of diabetic foot lesions. The classification system was developed to guide future surgical treatment protocols. Grading system: Grade 0 – no open lesion Grade 1 – superficial ulcer Grade 2 – deep ulcer Grade 3 – absess osteitis Grade 4 – gangrene forefoot Grade 5 – gangrene entire foot
4 Wagner Classification – validation Quality Indicator Type: Retrospective Analysis
Calhoun JH, Cantrell J, Cobos J, Lacy J, Valdex RR, Hokanson J, Mader JT. Treatment of Diabetic Foot Infections: Wagner Classification, Therapy, and Outcome. Foot & Ankle 1988;9(3):101-106.
In retrospective analysis, use of the Wagner classification system and therapy algorithms was shown to be a reasonable approach.
5 Falanga Staging system for wound bed preparation Quality Indicator Type: Scale Description
Falanga V. Classifications for wound bed preparation and stimulation of chronic wounds. Wound Repair and Regeneration 2000;8(5):347-352.
This well-known staging system was proposed by Dr. Vincent Falanga based on his clinical experience. It is a scoring system for wound bed preparation for all types of chronic wounds, since optimal treatment requires that the wound bed be prepared. The system consists of: an appearance score, A – D, based on granulation tissue, fibrinous tissue, and eschar and a wound exudate score, 1 – 3, based on extent of control, exudates amount, and dressing requirement.
6 Diabetic foot surgery classification system – validation Quality Indicator Type: Retrospective Analysis
Armstrong DG, Lavery LA, Frykberg RG, Wu SC, Boulton AJM. Validation of a diabetic foot surgery classification. Int Wound J 2006;3:240-246.
Medical records of 180 patients were reviewed to evaluate the validity of a classification system for non vascular diabetic foot surgery, i.e., Elective, Prophylactic, Curative, and Emergency, by examining the association with postoperative outcome. With increasing class of foot surgery, there was increased risk of ulceration or reulceration (P=0.0001), peri-postoperative infection (P=0.0001), all level amputation (P=0.0001), and major amputation (P=0.003). This study provides evidence of the validity of this nonvascular diabetic foot surgery classification system for predicting postoperative complications.
7 SINBAD classification system Quality Indicator Type: Scale Description
Ince P, Abbas ZG, Lutale JK, Basit A, Ali SM, Chohan F, Morbach S, Möllenberg J, Game FL, Jeffcoate WJ. Use of the SINBAD classification system and score in comparing outcome of foot ulcer management on three continents. Diabetes Care. 2008 May;31(5):964-7. Epub 2008 Feb 25.
The purpose of this study was to evaluate the clinical effectiveness of the SINBAD scale in predicting ulcer outcome. The SINBAD scale requires assessment of site, ischemia, neuropathy, bacterial infection and depth, and these variables are used to generate a single score. The results showed that time to healing increased with increasing SINBAD score. Consequently, the SINBAD score can be effectively used as a clinical assessment tool to predict ulcer outcome and to compare across different centres.
8 Foot infection in diabetic patients Quality Indicator Type: Validation study
Lavery LA, Armstrong DG, Murdoch DP, Peters EJ, Lipsky BA.. Validation of the Infectious Diseases Society of America’s diabetic foot infection classification system.. Clin Infect Dis. 2007 Feb 15;44(4):562-5. Epub 2007 Jan 17
Through a longitudinal study of 1666 diabetic patients, it was found that amputation, higher level amputation and lower extremity-related hospitalization all increase with increasing infection severity. Therefore, it is important to assess infection, and this can be achieved by using the Infectious Diseases Society of America’s diabetic foot infection classification system.
9 Foot Ulcer Classification Quality Indicator Type: Scale Description
Oyibo SO, Jude EB, Tarawneh I, Nguyen HC, Harkless LB, Boulton AJ. A comparison of two diabetic foot ulcer classification systems: the Wagner and the University of Texas wound classification systems. Diabetes Care. 2001 Jan;24(1):84-8.
The purpose of this study is to compare the Wagner and Texas Classification systems for diabetic foot ulcers with respect to their predictive abilities for outcomes. The results show that the Texas system is more effective, due to its inclusion of ulcer stage.

Vascular Issues

People with diabetes have an increased risk of atherosclerosis, and peripheral arterial disease (PAD) is approximately five times as common in the diabetic as the nondiabetic population. PAD is a contributing or the underlying cause of ulceration in approximately 25 to 30% of cases. In addition, the presence of vascular insufficiency can both determine the probability of ulcer healing and affect treatment choices.

The earliest symptom of PAD is intermittent claudication, leg pain or cramping when the patient is walking. As the vascular com promise becomes more severe, claudication may progress to rest pain or nocturnal leg pain. Leg pain is not diagnostic for PAD, as neuropathy may also cause leg pain. Similarly, absence of claudication does not exclude PAD, as pain may be absent in patients with neuropathy.

For these reasons, both clinical evaluation and appropriate investigations are necessary for a complete assessment of vascular status. History, physical and vascular examination and determination of the ankle-brachial index (ABI) comprise a minimum assessment. Physical examination of the feet and legs includes a search for clinical signs of vascular compromise, such as abnormal skin temperature and colour, increased capillary refill time, skin atrophy and dull, thickened nails. A vascular examination includes palpation and examination of femoral, popliteal, posterior tibial and dorsalis pedis pulses. Clinical examination provides an indicator of vascular status, but it is not a reliable way of either excluding or diagnosing PAD.

ABI is a simple, noninvasive and reliable technique for diagnosing vascular insufficiency. ABI is calculated by dividing the ankle systolic pressure by the brachial systolic pressure for each side of the body. A normal ABI is 1.0 [NEED TO VERIFY NORMAL—SOME AUTHORS STATE 0.9, OTHERS 0.95], and values less than this indicate varying degrees of vascular insufficiency, with lower values associated with more severe disease. The exception is the presence of calcified, non-compressible vessels, which may be seen in patients with longstanding diabetes and which increase ABI, sometimes above 1.0. Vessels in the toe are less likely to calcify, allowing the toe systolic pressure to be measured and the toe brachial index to be calculated. Transcutaneous oxygen tension determination provides a noninvasive measure of perfusion, the possibility of ulcer healing and post-amputation healing. Severe PAD is associated with transcutaneous oxygen readings significantly reduced below normal values (>40 mmHg).

A vascular surgery referral is appropriate for patients with likely or diagnosed PAD for a full assessment, including peripheral angiography, to diagnose PAD, facilitate ulcer treatment and determine the need for revascularization surgery.

Identify and Treat the Cause Level of Evidence
1 Perform a clinical evaluation of vascular status as part of the assessment of the diabetic foot, including history, physical examination and vascular examination. Not Assessed
2 Determine the ankle-brachial index for both legs as part of the vascular status assessment. Not Assessed
3 Obtain a toe brachial index or transcutaneous oxygen tension reading in patients in whom the ankle-brachial index indicates vessel calcification. Not Assessed
Address patient-centered Concerns Level of Evidence
4 Provide individualized education to enhance Glycemic control, Adherence to treatment, Plantar pressure redistribution/daily foot inspection. (GAP) Not Assessed
Provide Local Wound Care Level of Evidence
5 Refer patients with likely or diagnosed peripheral arterial disease for a vascular surgery evaluation for a definitive diagnosis, to plan ulcer treatment and to determine the need for revascularization surgery. Not Assessed
Provide Organizational Support Level of Evidence
6 Establish and empower an interprofessional team to work with Persons With Diabetes (PWD). Not Assessed

Essential Publications

1 AngioSeal Closure Device in Treatment of diabetics with critical limb ischemia Quality Indicator Type: Retrospective Analysis
Lupattelli T, Clerissi J, Clerici G, Minnella DP, Casini A, Losa S, Faglia E. The efficacy and safety of closure of brachial access using the AngioSeal closure device: experience with 161 interventions in diabetic patients with critical limb ischemia. J Vasc Surg. 2008 Apr;47(4):782-8. Epub 2008 Mar 4.
This study examines the effectiveness of closure of brachial access in patients with critical limb ischemia. The results demonstrate that the AngioSeal closure device is safe and effective brachial closure device, and ccan be implemented into practice
2 Peripheral Arterial Disease in analysis of the Diabetic Foot Quality Indicator Type: Cohort study (2 groups)
Prompers L, Schaper N, Apelqvist J, Edmonds M, Jude E, Mauricio D, Uccioli L, Urbancic V, Bakker K, Holstein P, Jirkovska A, Piaggesi A, Ragnarson-Tennvall G, Reike H, Spraul M, Van Acker K, Van Baal J, Van Merode F, Ferreira I, Huijberts M. Prediction of outcome in individuals with diabetic foot ulcers: focus on the differences between individuals with and without peripheral arterial disease. The EURODIALE Study. Diabetologia. 2008 May;51(5):747-55. Epub 2008 Feb 23.
The purpose of this study is to examine diabetic foot ulcer patients to determine the clinical characteristics which indicate poor outcomes. Furthermore, the study examines whether these factors are different for patients with or without peripheral arterial disease. The results show that infection has a much greater impact on diabetic patients with peripheral arterial disease. Consequently, the publication asserts that diabetic foot ulcers with and without peripheral arterial disease should be treated as two different disease states.