【医脉通-指南】2015+WHS指南：糖尿病足溃疡的治疗（英文更新版）.pdf

WHS Guidelines Update:Diabetic Foot Ulcer Treatment Guidelines Lawrence A.Lavery DPM,MPH,Department of Plastic Surgery,University of Texas Southwestern Medical Center,Dallas,Texas.Kathryn E.Davis,Ph.D.,Department of Plastic Surgery,University of Texas Southwestern Medical Center,Dallas,Texas.Sandra J.Berriman,Ph.D.,Cardinal Health Wound Management,Pompano Beach,FL Liza Braun,MD,Department of Dermatology,Emory University School of Medicine,Atlanta,GA Adam Nichols,DPM,Department of Orthopaedics,Sanford Health,Sioux Falls SD Paul J.Kim,DPM,MS,Department of Plastic Surgery,Georgetown University,School of Medicine,Washington,DC David Margolis,MD,PhD,Department of Dermatology,University of Pennsylvania Philadelphia,PA Edgar J.Peters,MD,PhD,Infectious Diseases and Topical Medicine,The Free University of Amsterdam,Amsterdam,the Netherlands.Chris Attinger,MD,Department of Plastic Surgery,Georgetown University,School of Medicine,Washington,DC Corresponding author:Lawrence A.Lavery University of Texas Southwestern Medical Center Department of Plastic Surgery 1801 Inwood Road,Dallas Texas 75390-9132 Fax [phone] Phone [phone] larry.laveryutsouthwestern.edu Running Title:DFU Guidelines Key Words:diabetes,foot,ulceration,infection,This article has been accepted for publication and undergone full peer review but has not beenthrough the copyediting,typesetting,pagination and proofreading process which may lead todifferences between this version and the Version of Record.Please cite this article as anAccepted Article,doi:10.1111/wrr.12391This article is protected by copyright.All rights reserved.There are 22.3 million people in the United States with diabetes,of whom 15-25%are at risk for foot ulceration.Diabetic foot ulcers(DFUs)are a growing health problem.DFUs are a leading cause of infection,amputation,and hospitalization in patients with diabetes mellitus.Guidelines for the treatment of DFUs were published by the Wound Healing Society(WHS)in 2006.However,in the past few years new evidence has emerged that improves our understanding of previous recommendations.The objectives of the WHS diabetic foot ulcer guidelines are to systematically evaluate the medical literature to assist clinicians in making health care decisions,identify areas that need additional research,and to clarify controversial diagnosis and treatment strategies.An advisory panel comprised of academicians,clinicians,researchers,and industry representatives was chosen to update the 2006 guidelines.METHODS In 2006,in an effort to develop guidelines that could provide clinicians with a reasonable approach to caring for patients,even in the absence of high quality human data,the WHS developed guidelines using a different 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 in 2006 guidelines were: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.Data sources and searches Since the 2006 guidelines,we sought to capture the highest quality of literature available regarding diabetic foot ulcer diagnosis and treatment using a key word search of Pubmed,Embase,and Cochrane Library databases.Similarly,the citations of relevant articles were examined by hand.Key terms were generated from the existing guidelines.In this search as opposed to the previous data collection prior to 2006,we used human and disease specific data and limited to meta-analyses,systematic reviews,randomized controlled trials(RCTs),retrospective series reviews,clinical case series,and expert panel recommendations published between January 2006 and present.References prior to 2006 supporting the original guideline recommendations are not included.Therefore in some cases no additional updated references were included and the support for the guideline recommendation is based on evidence presented in the 2006 guideline.Therefore no updated references are presented.It was Page 2 of 30Wound Repair and RegenerationManuscript under review-CONFIDENTIALThis article is protected by copyright.All rights reserved.further limited to only English publications.Any relevant additional references found after the formal search were also included.The findings of these articles have been divided into one or more of the appropriate categories as performed in the original guideline Each of the separate guidelines has undergone 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.The first draft was of the guidelines was presented in 2014 for public comment and subsequent drafts revised based on those comments.Evidence Reference:STAT Statistical analysis,meta-analysis,consensus RCT randomized clinical trial CLIN S clinical series LIT REV literature review GUIDELINES FOR THE DIAGNOSIS OF LOWER EXTREMITY DIABETIC ULCERS 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 over 20 million people in the United States with diabetes,of whom 15-25%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 40mmHg and/or hyperspectral imaging analysis 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.Updated Evidence:1.Hirsch AT,Haskal ZJ,Hertzer NR,Bakal CW,Creager MA,Halperin JL,et al.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 Page 3 of 30Wound Repair and RegenerationManuscript under review-CONFIDENTIALThis article is protected by copyright.All rights reserved.2.Potier,L,Halbron M,Bouilloud F,Dadon M,Le Doeuff J,Ha Van G,et al.Ankle-to-brachial ratio index underestimates the prevalence of peripheral occlusive disease in diabetic patients at high risk for arterial disease.Diabetes Care,2009.32(4):p.e44.CLIN SER 3.Guo X,Li J,Pang W,Zhao M,Luo Y,Sun Y,Hu D.Sensitivity and specificity of ankle-brachial index for detecting angiographic stenosis of peripheral arteries.Circ J,2008.72(4):p.605-10.CLIN SER 4.Nam SC,Han SH,Lim SH,Hong YS,Won JH,Bae JI,Jo J.Factors affecting the validity of ankle-brachial index in the diagnosis of peripheral arterial obstructive disease.Angiology,2010.61(4):p.392-6.CLIN SER 5.Favaretto E,Pili C,Amato A,Conti E,Losinno F,Rossi C,et al.Analysis of agreement between Duplex ultrasound scanning and arteriography in patients with lower limb artery disease.J Cardiovasc Med(Hagerstown),2007.8(5):p.337-41.CLIN SER 6.Allen J,Overbeck K,Nath AF,Murray A,Stansby G.A prospective comparison of bilateral photoplethysmography versus the ankle-brachial pressure index for detecting and quantifying lower limb peripheral arterial disease.J Vasc Surg,2008.47(4):p.794-802.CLIN SER 7.Aerden D,Massaad D,von Kemp K,van Tussenbroek F,Debing E,Keymeulen B,Van den Brande P.The ankle-brachial index and the diabetic foot:a troublesome marriage.Ann Vasc Surg,2011.25(6):p.770-7.CLIN SER 8.Xu D,Zou L,Xing Y,Hou L,Wei Y,Zhang J,et al.Diagnostic value of ankle-brachial index in peripheral arterial disease:a meta-analysis.Can J Cardiol,2013.29(4):p.492-8.STAT 9.Ozdemir BA,Brownrigg JR,Jones KG,Thompson MM,Hinchliffe RJ.Systematic review of screening investigations for peripheral arterial disease in patients with diabetes mellitus.Surg Technol Int,2013.23:p.51-8.STAT 10.Armstrong DW,Tobin C,Matangi MF.The accuracy of the physical examination for the detection of lower extremity peripheral arterial disease.Can J Cardiol,2010.26(10):p.e346-50.RETRO SER 11.Ruangsetakit C,Chinsakchai K,Mahawongkajit P,Wongwanit C,Mutirangura P.Transcutaneous oxygen tension:a useful predictor of ulcer healing in critical limb ischaemia.J Wound Care,2010.19(5):p.202-6.CLIN SER 12.Nouvong A,Hoogwerf B,Mohler E,Davis B,Tajaddini A,Medenilla E.Evaluation of diabetic foot ulcer healing with hyperspectral imaging of oxyhemoglobin and deoxyhemoglobin.Diabetes Care,2009.32(11):p.2056-61.CLIN SER 13.Urabe G,Yamamoto K,Onozuka A,Miyata T,Nagawa H.Skin Perfusion Pressure is a Useful Tool for Evaluating Outcome of Ischemic Foot Ulcers with Conservative Therapy.Ann Vasc Dis,2009.2(1):p.21-6.CLIN SER Page 4 of 30Wound Repair and RegenerationManuscript under review-CONFIDENTIALThis article is protected by copyright.All rights reserved.14.Yamada T,Ohta T,Ishibashi H,Sugimoto I,Iwata H,Takahashi M,Kawanishi J.Clinical reliability and utility of skin perfusion pressure measurement in ischemic limbs-comparison with other noninvasive diagnostic methods.J Vasc Surg,2008.47(2):p.318-23.CLIN SER Guideline#1.2:The presence of significant neuropathy can be determined by testing with a 10 gram(5.07)SemmesWeinstein monofilament.(Level II)Principle:Diabetic sensory neuropathy creates an environment in which repetitive trauma,injury and infection are unrecognized by the patient.Several simple clinical techniques can be used to identify sensory neuropathy with loss of protective sensation.The presence of sensory neuropathy can be determined by testing with a 10 gram Semmes Weinstein monofilament,128 hertz tuning fork,vibration perception threshold testing or a good neurological clinical examination for sensory loss.Updated Evidence:1.Oyer DS,Saxon D,Shah A.Quantitative assessment of diabetic peripheral neuropathy with use of the clanging tuning fork test.Endocr Pract,2007.13(1):p.5-10.CLIN SER 2.Richard JL,Reilhes L,Buvry S,Goletto M,Faillie JL.Screening patients at risk for diabetic foot ulceration.A comparison between measurement of vibration perception threshold and 10-g monofilament test.Int Wound J,2012.CLIN SER 3.Nather A,Neo SH,Chionh SB,Liew SC,Sim EY,Chew JL.Assessment of sensory neuropathy in diabetic patients without diabetic foot problems.J Diabetes Complications,2008.22(2):p.126-31.CLIN SER 4.Jurado J,Ybarra J,Pou JM.Isolated use of vibration perception thresholds and Semmes-Weinstein monofilament in diagnosing diabetic polyneuropathy:the North Catalonia diabetes study.Nurs Clin North Am,2007.42(1):p.59-66.CLIN SER 5.Mythili A,Kumar KD,Subrahmanyam KA,Venkateswarlu K,Butchi RG.A Comparative study of examination scores and quantitative sensory testing in diagnosis of diabetic polyneuropathy.Int J Diabetes Dev Ctries,2010.30(1):p.43-8.CLIN SER 6.Baraz S,Zarea K,Shahbazian HB,Latifi SM.Comparison of the accuracy of monofilament testing at various points of feet in peripheral diabetic neuropathy screening.J Diabetes Metab Disord,2014.13(1):p.19.CROSS SEC 7.Slater RA,Koren S,Ramot Y,Buchs A,Rapoport MJ.Pilot study on the significance of random intrasite placement of the Semmes-Weinstein monofilament.Diabetes Metab Res Rev,2013.29(3):p.235-8.CROSS SEC 8.Al-Geffari,M.Comparison of different screening tests for diagnosis of diabetic peripheral neuropathy in Primary Health Care setting.Int J Health Sci(Qassim),2012.6(2):p.127-34.CROSS SEC Page 5 of 30Wound Repair and RegenerationManuscript under review-CONFIDENTIALThis article is protected by copyright.All rights reserved.GUIDELINES FOR OFFLOADING FOR TREATMENT OF DIABETIC ULCERS Preamble:Diabetic ulcerations on the sole of the foot are often associated with moderate to high pressures because of foot deformity,limited joint mobility,and neuropathy.Off-loading devices reduce pressure on the sole of the foot and often reduce the activity level of the patient.Offloading the area of high pressure has been the mainstay to heal DFUs and prevent recurrence of foot ulcerations(Level I).Guideline#2.1:Protective footwear should be prescribed in any patient at risk for amputation(significant arterial insufficiency,significant neuropathy,previous amputation,previous ulcer formation,preulcerative callus,foot deformity,evidence of callus formation).(Level II)Protective footwear results in reduction in recurrent ulcerations in high-risk patients with a previous foot ulcer or amputation.(Level I).Principle:The etiology of many foot ulcers involves a biomechanical component.Most treatments do not eliminate the underlying biomechanical etiology of the foot ulcer.Abnormal pressure and shear stress is still present,so long-term offloading is necessary.By reducing pressure and shear forces on the sole of the foot,repetitive injury to the foot is reduced,and existing wounds can heal or high risk areas are protected from recurrent ulcers.Updated Evidence:1.Rizzo L,Tedeschi