Guidelines for the treatment of diabetic ulcers

Diabetic foot ulcers are a significant health care problem. Complications of foot ulcers are a leading cause of hospitalization and amputation in patients with diabetes mellitus. In response to a request from the Wound Healing Society, a panel of advisers, including physicians from academia and private practice, nurses, a podiatrist, a pedorthist, and a representative from industry, was selected to develop guidelines for the treatment of diabetic ulcers of the lower extremity. The approach used to develop guidelines was similar to that used by the Venous Ulcer Panel, also convened at the request of the Wound Healing Society. Those guidelines were presented on October 3, 2005, at a conference at the National Institutes of Health (NIH). Previous guidelines, meta-analyses, PubMed, MEDLINE, EMBASE, The Cochrane Database of Systematic Reviews, recent reviews of diabetic ulcer treatment, and the Medicare/CMS consensus of usual treatment of chronic wounds were reviewed for evidence. Guidelines were formulated, the underlying principle(s) enumerated, and evidence references listed and coded. The code abbreviations for the evidence citations were as follows: There was a major difference between our approach to evidence citations and past approaches to evidence-based guidelines. Most past approaches relied only on publications regarding clinical human studies. Laboratory or animal studies were not cited. We have used well-controlled animal studies that present proof of principle, especially when a clinical series corroborated the laboratory results. Because of this variation, a different system was used to grade the weight of evidence supporting a given guideline. The strength of evidence supporting a guideline is listed as Level I, Level II, or Level III. The guideline levels are: Level I: Meta-analysis of multiple RCTs or at least two RCTs supporting the intervention of the guideline. Another route would be multiple laboratory or animal experiments with at least two clinical series supporting the laboratory results. Level II: Less than Level I, but at least one RCT and at least two significant clinical series or expert opinion papers with literature reviews supporting the intervention. Experimental evidence that is quite convincing, but not yet supported by adequate human experience. Level III: Suggestive data of proof of principle, but lacking sufficient data such as meta-analysis, RCT, or multiple clinical series. Note: The suggestion in the guideline can be positive or negative at the proposed level (e.g., meta-analysis and two RCTs stating intervention is not of use in treating diabetic ulcers). Guidelines have been formulated in eight categories for the treatment of diabetic ulcers of the lower extremities. The categories are: Diagnosis Offloading Infection control Wound bed preparation Dressings Surgery Adjuvant agents (topical, device, systemic) Prevention of recurrence Each of the separate guidelines is undergoing a Delphi consensus among the panel members. Not all panel members thought they had sufficient expertise to critique all of the separate sections of the guidelines. However, each set of guidelines was critically evaluated by at least ten panel members. Preamble: Ulcers of the lower extremity may be caused by a variety of conditions, including neuropathy, ischemia, venous hypertension, and pressure. Patients with diabetes develop wounds secondary to neuropathy with or without biomechanical abnormalities, peripheral vascular disease with ischemia, or both. There are 20 million people in the United States with diabetes, of whom 10–15% are at risk for ulceration. It is imperative that the etiology be established to provide for proper therapy. Guideline #1.1: Clinically significant arterial disease should be ruled out by establishing that pedal pulses are clearly palpable or that the ankle : brachial index (ABI) is >0.9. An ABI >1.3 suggests noncompressible arteries. In elderly patients or patients with an ABI >1.2, a normal Doppler-derived waveform, a toe : brachial index of >0.7, or a transcutaneous oxygen pressure of >40 mmHg may help to suggest an adequate arterial flow. Color duplex ultrasound scanning provides anatomic and physiologic data confirming an ischemic etiology for the leg wound. (Level I) Principle: Diabetic ulcers can result from arterial insufficiency or neuropathy. Although clinical history and physical examination can be very suggestive of an ischemic etiology of the lower extremity diabetic ulcers, a definitive diagnosis must be established. When significant arterial disease is present, successful treatment requires that arterial insufficiency be addressed. Evidence: Sahli D, Eliasson B, Svensson M, Blohme G, Eliasson M, Samuelsson P, Ojbrandt K, Eriksson J. Assessment of toe blood pressure is an effective screening method to identify diabetes patients with lower extremity arterial disease. Angiology 2004; 55: 641–51. CLIN S Teodorescu V, Chen C, Morrissey N, Faries P, Marin M, Hollier L. Detailed protocol of ischemia and the use of noninvasive vascular laboratory testing in diabetic foot ulcers. Am J Surg 2004; 187 (5A): 75S–80. LIT REV Hirsch A, Criqui M, Treat-Jacobson D, Regensteiner J, Creager M, Olin J, Krook S, Hunninghake D, Comerota A, Walsh M, McDermott M, Hiatt W. Peripheral arterial disease detection, awareness, and treatment in primary care. JAMA 2001; 286: 1317–24. CLIN S Ascher E, Hingorani A, Markevich N, Yorkovich W, Schutzer R, Hou A, Jacob T, Nahata S, Kallakuri S. Role of duplex arteriography as the sole preoperative imaging modality prior to lower extremity revascularization surgery in diabetic and renal patients. Ann Vasc Surg 2004; 18: 433–439. CLIN S Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA, Halperin JL, Hiratzka LF, Murphy WRC, Olin JW, Puschett JB, Rosenfield KA, Sacks D, Stanley JC, Taylor LM Jr, White CJ, White J, White RA. ACC/AHA guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society for Vascular Medicine and Biology, and the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (writing committee to develop guidelines for the management of patients with peripheral arterial disease). American College of Cardiology Web site. Available at: http://www.acc.org/clinical/guidelines/pad/index.pdf. STAT Padberg FT, Back TL, Thompson PN, Hobson RW. Transcutaneous oxygen (TcPO2) estimates probability of in the ischemic extremity. J Surg CLIN S Guideline The of significant neuropathy can be by testing with a (Level Principle: to foot with pressure on the especially the of in of pressure. neuropathy may the of Evidence: N, D, foot ulcers in patients with JAMA LIT REV N, K, S, T, K, R, M, of examination for diabetic peripheral neuropathy J Complications CLIN S K, S. of a for of foot in patients with J Surg 2004; CLIN S A, P, V, V, J. of patients at risk for diabetic a of noninvasive testing with at diabetes J Complications 2001; CLIN S J, J. The use of the and for foot and amputation in with J LIT REV D, C, J, to identify people at risk for diabetic foot a CLIN S M, D, D, E, J, examination for the of in the of diabetic patients. for J CLIN S S, D, A, E, M, a effective and screening for diabetic patients at risk of foot ulceration. CLIN S J, R, P, of pressure in diabetic peripheral neuropathy. 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Surg LIT REV C, control and the risk of in a of with CLIN S Preamble: There is a of for treatment of diabetic ulcers. bed with Guidelines are to help the regarding the and use of care Most be used in with and of the Guideline a that a (Level Principle: and of wounds by also Evidence: of and on the of a wound. K, Eriksson E, P, Healing of wounds in a J Surg T, B, J, Eriksson of wounds in a Surg J, S, N, T, S, K, R, J, D, Eriksson Surg CLIN S Guideline clinical to a (Level Principle: are not are as effective as of in of Evidence: The of two on J Surg P, M, of J Surg J, S, S. Healing of J Wound M, N, M, T, Systematic reviews of care and agents used in the of chronic Health STAT of a in the management of diabetic foot ulcers. Wound CLIN S Guideline a that the and the (Level I) Principle: and with can the and Evidence: B, of by chronic Wound S, N, J, Murphy G, of the and chronic the of and Wound Wound from human pressure ulcers levels and to J J, S, S. 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Surg Am LIT REV S, L. of the in diabetic patients are at risk for of the J Surg CLIN S with of the ankle in diabetic the of and CLIN S for the treatment of ulcers a in pressure with in than ankle J 2004; CLIN S Guideline Patients with ischemia should be for a revascularization Principle: In patients with arterial in blood is with an in and Evidence: P, on Wound Healing and for with Diabetic 2004; LIT REV T, Vascular and of the diabetic Surg LIT REV K, and clinical of arterial in diabetic and of J Vasc Surg CLIN S E, M, M, use of peripheral in the treatment of diabetic foot clinical of a of diabetic J CLIN S D, extremity revascularization in Surg CLIN S A, arterial for foot ischemia in patients with diabetes mellitus. J Vasc Surg CLIN S Preamble: agents have been to be used as to and in the treatment of diabetic ulcers. agents can be agents to be to the at ulcer and to the of agents have evidence to guidelines regarding Guideline is effective in treating diabetic foot ulcers. (Level I) Principle: are in Evidence: D, Diabetic Ulcer of human for the treatment of lower extremity diabetic ulcers. J Vasc Surg J, J, and of a of human in patients with chronic diabetic a in patients with lower extremity ulcers. J, and of human in patients with lower extremity diabetic a of studies. Wound STAT J, V, D, the of clinical with the that is an effective to the treatment of diabetic foot ulcers. J STAT Guideline not yet have data on to of for treatment of diabetic ulcers, suggest (Level I) Principle: are in Evidence: in chronic diabetic foot ulcers. G, D, M, T, response of in diabetic S, J, D, of in of ulcers. Surgery D, K, V, and treatment of chronic ulcers Surg D, K, V, S, E, of in ulcers Surg JL, C, of on the of chronic diabetic ulcer of the 18: of on in diabetic foot ulcers. J of ulcers in patients with diabetes by treatment with Wound S, S, in foot ulcers. Diabetic CLIN S G, M, G, P, P, of as for diabetic foot 2001; A, M, N, J, of in diabetic foot W, G, C, of diabetic foot ulcers. Guideline pressure may be of in treating diabetic (Level I) Principle: treatment may by and the of the and should be when are not Evidence: M, K, G, J, of for diabetic foot Ann Vasc Surg S, C, J, M, J, L. in the of diabetic foot D, L. Diabetic negative pressure diabetic foot a M, T, S, R, D, L. with the negative pressure in the treatment of diabetic and S] D, C, A, R, R, J. Guidelines regarding negative in the diabetic 2004; LIT REV D, L. negative pressure for treating chronic Cochrane Database 2001; STAT Guideline may be of in diabetic foot ulcers. (Level I) Principle: in diabetic foot ulcers by of and that the Evidence: P, Diabetic Ulcer the and of in the of chronic diabetic foot of a A, V, Diabetic Ulcer a human is effective in the management of diabetic foot a clinical 2001; Healing of chronic foot ulcers in diabetic patients with a human J Surg J, P, K, The of treatment of diabetic foot ulcers. STAT J, T, Hollier L. Healing of diabetic foot ulcers and pressure ulcers with human a in Surg CLIN S a use in the treatment of venous leg ulcers and diabetic foot ulcers. LIT REV a human for the treatment of chronic diabetic foot ulcers. 2004; LIT REV Guideline may be of in diabetic foot ulcers. (Level I) Principle: of to wounds may and Evidence: for a of evidence from in animal and clinical J LIT REV P, C, M, K, D, M, of on chronic leg ulcer and T, Eriksson S, of diabetic ulcers. Ann Surg of on the of wounds in diabetic Wound 2001; as an to diabetic foot a clinical 2001; Guideline oxygen may be of in the amputation in patients with ischemic diabetic foot ulcers. (Level I) Principle: oxygen may the of oxygen to a in diabetic patients and Evidence: C, S, E, D, J. oxygen for treating a of the Surg LIT REV A, G, G, B, A, P, E, The of oxygen in ischemic diabetic lower extremity a J Vasc Surg A, G, G, B, Role of oxygen in a J Surg 2001; E, A, P, A, G, M, P, oxygen in treatment of ischemic diabetic foot T, Chen S, The vascular of oxygen in treatment of diabetic 2001; CLIN S C, oxygen of chronic leg a Surg P, C, R, D, M, the of chronic diabetic foot a P, M, I, S. oxygen for chronic Cochrane Database STAT oxygen lower extremity and the diabetic LIT REV Preamble: Diabetic ulcers of the lower extremity are a chronic problem. are must be for ulcers. Guideline Patients with diabetic ulcers should use to (Level Principle: Most not the underlying pressure on the is Evidence: M, G, D, C, S, of diabetic in 2004; LIT REV for people with 2004; 20 LIT REV and the diabetic clinical and Am J Surg 2004; 187 (5A): LIT REV management of the diabetic 2001; LIT REV R, R, G, K, W, of on foot as by in diabetic a 2001; 18: E, G, A, A, P, in the of diabetic foot ulcers. 18: S, V, Taylor L. of to in people with CLIN S A, in treatment of diabetic ulcers. clinical CLIN S Guideline foot care and of the the recurrence of diabetic ulceration. (Level Principle: foot care including proper and proper in diabetic Evidence: M, M, E, of American and Society. Guidelines for diabetic foot by the of the American and Society. LIT REV W, P, on Wound Healing and for with Diabetic Wound and for people with diabetic foot ulcers. 2004; 20 LIT REV The diabetic LIT REV foot in patients with diabetes mellitus. J STAT of foot in patients with STAT K, and lower extremity risk and in CLIN S was supported by the Wound Healing a to the Wound Healing Society.