Guidelines for the prevention of diabetic ulcers

The Wound Healing Society (WHS) is a professional society of physicians, nurses, physical therapists, podiatrists, and other wound care specialists, basic scientists, clinical researchers, and industrial researchers dedicated to assuring that every patient receives optimal wound care. Its mission is to advance the science and practice of wound healing. To that end, the following comprehensive, evidence- and consensus-based guidelines were developed to address The Prevention of Diabetic Ulcers. The guidelines are presented in generic terms; the details of specific tests, therapies, and procedures are at the discretion of an interdisciplinary team of health care professionals who establish, implement, and evaluate policies and procedures directed at prevention of diabetic ulcers. PubMed, EMBASE, CINAHL, and the Cochrane Database of Systematic Reviews were searched and reviewed for evidence on arterial insufficiency ulcer prevention. In addition, a search of health care databases for current evidence-based guidelines addressing the prevention of diabetic ulcers was conducted using electronic and online resources. The panel classified studies based on whether the intervention being evaluated addressed diabetic ulcer risk screening and assessment, diabetic ulcer prevention plans of care (including interdisciplinary approaches), or patient and caregiver education. Evidence references for each standard are listed and coded. The code abbreviations for the evidence citations were as follows: The strength of evidence supporting a guideline is listed as Level I, Level II, or Level III, using the following definitions: Level I: Meta-analysis of multiple RCTs or at least two RCTs supporting the intervention in the guideline or multiple laboratory or animal experiments with at least two clinical series supporting the laboratory results. Level II: Less evidence 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 without support 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. Cowie CC, Rust KF, Byrd-Holt DD, Eberhardt MS, Flegal KM, Engelgau MM, Saydah SH, Williams DE, Geiss LS, Gregg EW. Prevalence of diabetes and impaired fasting glucose in adults in the U.S. population: National Health and Nutrition Examination Survey. Diabetes Care 2006; 29: 1263–8. Chetty VK, Bruce Zellner B. Use of survey and clinical data for screening and diagnosis. Stat Med 2007; 26: 3213–28 [Epub]. Singh N, Armstrong DG, Lipsky BA. Preventing foot ulcers in patients with diabetes. JAMA 2005; 293: 217–28. Preamble: Patients with diabetes develop wounds as a result of neuropathy, peripheral vascular disease with ischemia, or both. In 2002, there were 19.3 million people with diabetes mellitus, for a crude incidence of 9.3%. The diagnosis of diabetes had been established in 6.5%, with 2.8% undiagnosed. There are now an estimated 20.8 million people in the United States with diabetes. As many as 25% of these patients are at risk for ulceration during their lifetimes. Preventing wounds may reduce the likelihood of amputation. Establishing the proper diagnosis is imperative, as is evaluation of the patient for the complications of diabetes. Prevention of wounds in these patients involves addressing these complications before ulceration. 1. Identifying Complications of Diabetes Leading to Ulceration: Guideline #1.1: In patients with diabetes, 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 wave form, 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 atherosclerotic occlusive disease. Level of Evidence: I. Principle: Diabetic ulcers can result from minor trauma in patients with arterial insufficiency. Although clinical history and physical examination can be suggestive of ischemia of the lower extremity in a patient with diabetes, a definitive diagnosis must be established. 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–80S [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: 433–9 [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 healing in the ischemic extremity. J Surg Res 1996; 60: 365–9 [CLIN S]. Guideline #1.2: The presence of significant neuropathy that can render a patient at risk of foot ulceration can be determined by testing with a 10 g (5.07) Semmes–Weinstein monofilament. Monofilament testing should be combined with a clinical examination of the lower extremity that focuses on the possible existence of foot deformity and a symmetric sensory level below which there is reduced sensation to pain, touch and vibration in both limbs. Level of Evidence: II. Principle: The most important causative factor of diabetic foot ulcers is peripheral neuropathy. Neuropathy leads to foot deformity with abnormal pressure on the foot, especially the plantar surface. Lack of protective sensation allows ulceration in areas of high pressure. Autonomic neuropathy may increase the likelihood of skin breakdown. Evidence: Singh N, Armstrong D, Lipsky B. Preventing foot ulcers in patients with diabetes. JAMA 2005; 293: 217–28 [LIT REV]. Kamei N, Yamane K, Nakanishi S, Yamashita Y, Tamura T, Ohshita K, Watanabe H, Fujikawa R, Okubo M, Kohno N. Effectiveness of Semmes–Weinstein monofilament examination for diabetic peripheral neuropathy screening. J Diabetes Complications 2005; 19: 47–53 [CLIN S]. Foltz K, Fallat L, Schwartz S. Usefulness of a brief assessment battery for early detection of Charcot foot deformity in patients with diabetes. J Foot Ankle Surg 2004; 43: 87–92 [CLIN S]. Jirkovska A, Boucek P, Woskova V, Bartos V, Skibova J. Identification of patients at risk for diabetic foot: a comparison of standardized noninvasive testing with routine practice at community diabetes clinics. J Diabetes Complications 2001; 15: 63–8 [CLIN S]. Mayfield J, Sugarman J. The use of the Semmes–Weinstein monofilament and other threshold tests for preventing foot ulceration and amputation in persons with diabetes. J Fam Pract 2000; 49 (11 Suppl.): S17–29 [LIT REV]. Pham H, Armstrong D, Harvey C, Harkless L, Giurini J, Veves A. Screening techniques to identify people at high risk for diabetic foot ulceration: a prospective multicenter trial. Diabetes Care 2000; 23: 606–11 [CLIN S]. Smieja M, Hunt D, Edelman D, Etchells E, Cornuz J, Simel D. Clinical examination for the detection of protective sensation in the feet of diabetic patients. International Cooperative Group for Clinical Examination Research. J Gen Intern Med 1999; 14: 418–24 [CLIN S]. Kumar S, Fernando D, Veves A, Knowles E, Young M, Boulton A. Semmes-Weinstein monofilaments: a simple, effective and inexpensive screening device for identifying diabetic patients at risk of foot ulceration. Diabetes Res Clin Pract 1991; 13: 63–7 [CLIN S]. Holewski J, Stess R, Graf P, Grunfeld C. Aesthesiometry. Quantification of cutaneous pressure sensation in diabetic peripheral neuropathy. J Rehabil Res Dev 1988; 25: 1–10 [CLIN S]. Lavery LA, Armstrong DG, Vela SA, Quebedeaux TL, Fleischli JC. Practical criteria for screening patients at high risk for diabetic foot ulceration. Arch Int Med 1998; 158: 157–62 [CLIN S]. 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. Diab Care 2003; 26: 1069–73 [CLIN S]. Litzelman DK, Marriott DJ, Vinicor F. Independent physiological predictors of foot lesions in patients with NIDDM. Diab Care 1997; 20: 1273–8 [RCT]. Guideline #1.3: In patients with diabetes, laboratory values such as hemoglobin A1c should be monitored. Level of Evidence: II. Principle: High glucose concentrations in the blood lead to increased glycation of the hemoglobin molecules to form hemoglobin A1C, which persists in circulation for up to 6 weeks. Therefore, measurement of plasma hemoglobin A1C is the accepted standard for monitoring long-term glucose control. Elevated hemoglobin A1C levels have been correlated with a variety of comorbidities of diabetes, such as cardiovascular and/or coronary heart disease, retinopathy, neuropathy, and nephropathy/renal failure. Elevated hemoglobin A1C has been shown to be a predictive factor in the development of diabetic foot ulcers but further research is still required. Evidence: Valeri D, Pozzilli P, Leslie D. Glucose control in diabetes. Diabetes Metab Res Rev 2004; 20 (Suppl. 2): S1–8 [LIT REV]. Roberts SR, Hamedani B. Benefits and methods of achieving strict glycemic control in the ICU. Crit Care Nurs Clin North Am 2004; 16: 537–45 [LIT REV]. Goldstein DE, Little RR, Lorenz RA, Malone JI, Nathan DM, Peterson CM, American Diabetes Association. Tests of glycemia in diabetes. Diabetes Care 2004; 27 (Suppl. 1): S91–3 [STAT]. Stratton IM, Adler AI, Neil HA, Matthews DA, Manley SA, Cull CA, Hadden D, Turner RC, Holman RP. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ 2000; 321: 405–12 [CLIN S]. The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993; 329: 977–86 [RCT]. Schellhase KG, Koepsell TD, Weiss NS. Glycemic control and the risk of multiple microvascular diabetic complications. Fam Med 2005; 37: 125–30 [RETRO S]. UK Prospective Diabetes Study (UKPDS) Group. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet 1998; 352: 854–65 [RCT]. 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 2006; 29: 1202–27 [CLIN S]. 2. Perform Foot Exam for Clinical Manifestations of Diabetes that Increase Risk of Ulceration: Guideline #2.1: Patients with diabetes should have an annual foot exam. Level of Evidence: I. Principle: Published guidelines uniformly recommend that all diabetic patients have an annual foot examination that includes assessment for anatomic deformities, skin breaks, nail disorders, loss of protective sensation, diminished arterial supply, and improper footwear. People with higher risk for foot ulceration should have more frequent foot exams. Evidence: Singh N, Armstrong DG, Lipsky BA. Preventing foot ulcers in patients with diabetes. JAMA 2005; 293: 217–28 [LIT REV]. Frykberg RG, Armstrong DG, Giurini JM, Edwards A, Kravette M, Kravitz S, Ross C, Stavosky J, Stuck R, Vanore J, American College of Foot and Ankle Surgeons. Diabetic foot disorders: a clinical practice guideline. J Foot Ankle Surg 2000; 39: S1–60 [STAT]. Hutchinson A, McIntosh A, Feder G, Home PD, Young R. Clinical guidelines for type 2 diabetes: prevention and management of foot problems. London, UK: J Roy Col Gen Practitioners, 2000 [STAT]. International Consensus on the Diabetic Foot: Practical Guidelines [book on CD-ROM]. Noordwijkerhout, the Netherlands: International Working Group on the Diabetic Foot, 1999 [STAT]. Supplement to the International Consensus on the Diabetic Foot: Practical Guidelines [book on CD-ROM]. Noordwijkerhout, the Netherlands: International Working Group on the Diabetic Foot, 2003 [STAT]. U.S. Veterans Health Administration/Department of Defense. Clinical practice guidelines: diabetes mellitus algorithms—Module F: Foot Care. Washington, DC: Veterans Health Administration, 2003 [STAT]. Mayfield JA, Reiber GE, Sanders LJ, Janisse D, Pogach LM, American Diabetes Association. Preventive foot care in people with diabetes. Diabetes Care 2004; 27 (Suppl. 1): S31–2 [STAT]. Guideline #2.2: Patients with diabetes should be examined for callus formation. Level of Evidence: III. Principle: Callus formation, particularly with hemorrhage, is a sign of skin and ulceration. of the callus in plantar Evidence: H, P, Boulton protocol for diabetic foot ulcers. Surg 2006; Suppl.): [LIT REV]. Boulton P, Diabetic foot a for prevention and care. Wound 1999; [LIT REV]. Guideline Patients with diabetes should be examined for Level of Evidence: III. Principle: a of the of patients with diabetes and is the of that can to the by the and and intervention. Evidence: N, P, P, R, Prevalence and of a J 1998; [CLIN S]. R. and for J Am Med 2006; [LIT REV]. LA, P, J, R, E, C, A. The of on of development of an to patient of J Am 1999; [CLIN S]. S. The and management of in diabetic patients. J 2000; [LIT REV]. and in patients with diabetes. J Am 2000; 43: [LIT REV]. of in the diabetic patient J Diabetes Complications 2003; [LIT REV]. R, DJ, W, I. for of the skin and of the Cochrane Database Rev [STAT]. RC, An of in a North American 1998; 55: [LIT REV]. to Ulceration: Guideline pressure on areas of the diabetic foot in callus formation, which can lead to ulceration. of callus reduce the likelihood of ulceration. Level of Evidence: I. Principle: callus reduce pressure in areas at increased risk for all should be with Evidence: Young S, Boulton AJ. The association callus formation, high and neuropathy in diabetic ulceration. Med 1996; 13: [CLIN S]. R, A, High plantar pressure and callus in diabetic J Am Med 2003; [CLIN S]. RA, I, Y, A, in plantar pressure by and Diabetes Res Clin Pract 2006; [CLIN S]. A, L, J, V, B, The of on the and of plantar pressure in patients with diabetes mellitus. callus may of plantar pressure Diabetes Metab [CLIN S]. Young G, MM, H, Boulton AJ. The effect of callus on plantar foot in diabetic patients. Med [CLIN S]. A, The effect of callus on foot J Foot Ankle Surg 1999; [CLIN S]. H, P, Boulton protocol for diabetic foot ulcers. Surg 2006; Suppl.): [LIT REV]. Guideline plantar pressure. may be for patients with history of foot ulceration in all other care has Level of Evidence: II. Principle: plantar pressure is with a in risk of ulceration. Evidence: for the treatment of ulcers of in pressure with in plantar than during J 2004; 37: [RCT]. Effect of on plantar ulcers. clinical trial. J Surg Am 2003; [RCT]. Armstrong DG, S, H, Harkless of the in diabetic patients who are at high risk for ulceration of the J Surg Am 1999; [CLIN S]. of a on and in a patient with diabetes mellitus. J 2000; [CLIN S]. the for the treatment of diabetic plantar ulceration. Surg Clin North Am 2003; [LIT REV]. the Diabetic Foot: Guideline should be in patient at risk for ulceration arterial significant neuropathy, or Level of Evidence: II. Principle: Diabetic ulceration may result from an increase in pressure in the diabetic foot of foot deformity and neuropathy. the of high pressure. The incidence of ulceration in diabetic patients at risk can be reduced by using protective footwear. should be in patient at risk for amputation as significant arterial significant neuropathy, ulcer formation, foot or evidence of callus Evidence: Janisse D. The for for diabetic patients. Foot Ankle Int 2005; 26: [CLIN S]. M, M, E, N. Diabetes of American Foot and Ankle Guidelines for diabetic foot by the Diabetes of the American Foot and Ankle Foot Ankle Int 2005; 26: [LIT REV]. Reiber GE, DG, C, K, S, C, Heagerty J. Effect of on foot in patients with diabetes: a trial. JAMA [RCT]. Reiber GE, DG, C, S, Boyko Effectiveness of diabetic in preventing Diabetes Care 2004; [LIT REV]. E, T, effective is in diabetic clinical study. Med [CLIN S]. E, An of diabetic to patient Med [CLIN S]. L, E, G, L, A, A, P, in the prevention of diabetic foot ulcers. Diabetes Care 18: [RCT]. Giurini JM, Veves A. foot pressure by in high risk diabetic patients. Diabetes Res Clin Pract 1996; [CLIN S]. Veves A, Giurini JM, foot pressure in diabetic patients with at risk feet and Diabetes Care [CLIN S]. Guideline Patients with diabetic ulcers should use protective to Level of Evidence: II. Principle: Diabetic ulcers of the lower extremity are a are Therefore, long-term must be addressed for ulcers. the increased pressure on the foot, is Evidence: M, Reiber G, D, C, S, Boyko Effectiveness of diabetic in preventing Diabetes Care 2004; [LIT REV]. for people with diabetes. Diabetes Metab Res Rev 2004; 20 (Suppl. 1): [LIT REV]. Boulton AJ. and the diabetic foot: clinical science and Am J Surg 2004; 187(5A): [LIT REV]. MS, management of the diabetic Foot Ankle Clin 2001; [LIT REV]. R, R, G, K, W, of on foot as determined by in diabetic a prospective study. Med 2001; 18: [RCT]. L, E, G, L, A, A, P, in the prevention of diabetic foot ulcers. Diabetes Care 18: [RCT]. S, L, V, Taylor L. Use of to callus in people with diabetes. Diabetes Res Clin Pract [CLIN S]. A, DA, in treatment of diabetic plantar ulcers. clinical trial. Diabetes Care [CLIN S]. Reiber GE, DG, C, Effect of on foot in patients with diabetes: a trial. JAMA [RCT]. Foot Guideline foot care and of the feet reduce the incidence of diabetic ulceration. may be for a or caregiver to help with these Level of Evidence: II. Principle: foot proper and nail and the use of proper reduce ulceration in diabetic Evidence: M, M, E, Diabetes of American Foot and Ankle Guidelines for diabetic foot by the Diabetes of the American Foot and Ankle Foot Ankle Int 2005; 26: [LIT REV]. W, P, International Working Group on Wound Healing and for People with Diabetic Foot Ulcers. Wound healing and for people with diabetic foot ulcers. Diabetes Metab Res Rev 2004; 20 1): [LIT REV]. The diabetic [LIT REV]. Marriott DJ, Vinicor Litzelman foot lesions in patients with diabetes mellitus. J Gen Intern Med 1998; 13: [STAT]. Litzelman DK, Marriott DJ, Vinicor F. Independent physiological predictors of foot lesions in patients with NIDDM. Diab Care 1997; 20: 1273–8 [STAT]. K, Diabetes and lower extremity risk and in Diab Care 1996; 19: [CLIN S]. Guideline of patients with diabetes, at preventing foot may reduce the incidence of ulceration and especially in patients. Level of Evidence: II. Principle: of using a diabetes may help to practice foot care Evidence: DM, for preventing diabetic foot ulceration. Cochrane Database Rev [STAT]. MA, Reiber GE, Koepsell and patient of for lower extremity amputation foot care Diab Care [CLIN S]. Singh N, Armstrong DG, Lipsky BA. Preventing foot ulcers in patients with diabetes. JAMA 2005; 293: 217–28 [LIT REV]. MS, E, Diabetes of the American Foot and Ankle Guidelines for diabetic foot by the Diabetic of the American Foot and Ankle Foot Ankle Int 2005; 26: [STAT]. EJ, Ahroni JH, V, RC, prospective of risk for diabetic foot the Seattle Diabetic Foot Study. Diabetes Care 1999; [CLIN S]. N, CA, A, P, Boulton AJ. Risk of amputation in in the Med 19: [CLIN S]. IM, Prevalence and predictors of diabetic foot in type 2 diabetes mellitus in Med J 2003; [CLIN S]. Guideline of patients with risk for lower extremity amputation may reduce the risk of ulceration. Level of Evidence: III. Principle: who are of patients with increased risk of foot ulceration are more to foot care Evidence: MA, Reiber GE, Koepsell and patient of for amputation Diab Care [CLIN S].