Local wound care

Recommendations

Identify and Treat the Cause
1 Take a careful history (general history, diabetic control and complications). Level of Evidence
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 Level of Evidence
Not Assessed
3 Select and consistently apply an accepted wound classification system to assess diabetic foot ulcers. Level of Evidence
Not Assessed
4 Assess wound area, depth and infection initially to determine a treatment plan and regularly to determine its effectiveness. Level of Evidence
Not Assessed


Address patient-centered Concerns
5 Provide individualized education to enhance Glycemic control, Adherence to treatment, Plantar pressure redistribution/daily foot inspection. (GAP) Level of Evidence
Not Assessed
6 Provide patient and caregiver education about the need for reduced wound pressure to support healing. Level of Evidence
Not Assessed


Provide Local Wound Care
7 Assess and document healing with ulcer duration, location, size, and depth (probe to bone). Level of Evidence
Not Assessed
8 Optimize wound healing environment through Debridement, Infection (bacterial burden control) and Moisture balance. (DIM) Level of Evidence
Not Assessed
9 For stalled wounds, consider the use of biological agents and adjunctive therapies (edge effect). DIM/E Level of Evidence
Not Assessed
10 Debride infected and/or contaminated nonviable tissue using an appropriate debridement method. Level of Evidence
Not Assessed
11 Provide an optimum environment for wound healing with attention to debridement, infection control and moisture balance. Level of Evidence
Not Assessed
12 Control wound bacterial balance using debridement and broad-spectrum topical antimicrobials if necessary. Level of Evidence
Not Assessed
13 Institute systemic antimicrobial therapy if a 2-week course of topical treatment does not improve the wound environment. Level of Evidence
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. Level of Evidence
Not Assessed


Provide Organizational Support
15 Establish and empower an interprofessional team to work with Persons With Diabetes (PWD). Level of Evidence
Not Assessed


Background

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.

References

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


Enablers for practice

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