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  ManagementofaDiabeticFoot TheodoreHart,MD;RossMilner,MD;AdamCifu,MD SummaryoftheClinicalProblem Diabetes affects more than 29 million people in the United Statesand415millionpeopleworldwide. 1 Theprevalenceisincreasingandexpectedtoexceed640millionpeoplein2040. 1 Presently,asmanyas1in4patientswithdiabetesdevelopsaDFU,ofwhichatleastone-quarter do not heal, putting patients at risk of amputation. 2 Theguideline focuses on interventions that decrease the burden andcosts of all stages of diabetic foot syndrome; this synopsis specifi-callyreviewsthepreventativemeasuresconsidered. CharacteristicsoftheGuidelineSource Guideline development was sponsored by the SVS in collaborationwith the American Podiatric Medical Association and Society forVascular Medicine and used the GRADE framework. These organi-zations selected a multidisciplinary committee of vascular sur-geons, podiatrists, and physicians with expertise in vascular andinternal medicine to form the Diabetic Foot Practice GuidelinesCommittee. A guideline methodologist, a librarian, and a team of investigators with experience in conducting systemic review andmeta-analysis assisted the committee. Five full systematic reviewsand meta-analyses were published concomitant to the guideline.The committee used the evidence as well as unanimous expertconsensus to formulate its recommendations. The final guidelineswere peer reviewed by the SVS documents oversight committee.All committee members completed conflict of interest disclosuresand more than 50% of the writing group was free of relevant con-flicts; the chair overseeing the guideline development had no rel-evantconflicts 3 ( Table ). EvidenceBase Severalsmallprospectivestudiessupportrecommendationsforan-nualfootexaminationsandeducationofpatientsandfamilymem-bers. One trial randomized 145 patients with diabetes and historyoffootulcertomultidisciplinarycarebyfootspecialistswithaccessto footwear and education as well as quarterly primary carefollow-upvsquarterlyprimarycarefollow-upandeducationalone. 4 Therateofrecurrentulcerintheinterventiongroupwas30.4%at2 years vs 58.4% in the control group (odds ratio [OR], 0.31; 95%CI,0.14-0.67). 4 Use of the Semmes-Weinstein test is supported by numerousstudies. 5 Inareviewof6prospectivestudiesand10observationalstudies,positivetestresultswereassociatedwithORsbetween2.2and9.9forthedevelopmentofulcersat1-or2-yearfollow-up. 6 A meta-analysis was performed to assess the accuracy of tests to predict wound healing. Observational data were availablefor studies that assessed ABI (20 studies; 2376 patients) andTcP O 2  (25 studies; 3789 patients). 7 An ABI threshold of less than0.8 was predictive of amputation (OR, 2.89; 95% CI, 1.65-5.05)but not complete ulcer healing (OR, 1.02; 95% CI, 0.40-1.65). 7 Table.GuidelineRating Standard Rating Establishing transparency GoodManagement of conflict of interest in the guidelinedevelopment groupGoodGuideline development group composition FairClinical practice guideline–systematic review intersection GoodEstablishing evidence foundations and rating strengthfor each of the guideline recommendationsGoodArticulation of recommendations GoodExternal review FairUpdating FairImplementation issues Good GUIDELINETITLE ManagementofaDiabeticFoot DEVELOPER SocietyforVascularSurgery(SVS),AmericanPodiatricMedicalAssociation,SocietyforVascularMedicine RELEASEDATE February2016 FUNDINGSOURCE SVS TARGETPOPULATION Allpatientswithdiabetes MAJORRECOMMENDATIONSANDRATINGS (1)Annualfootinspectionsbyphysiciansoradvancedpracticeclinicianswithtraininginfootcareandeducationofpatientsandtheirfamiliesaboutpreventivefootcarearerecommendedforpatientswithdiabetes(grade1C).(2)FootexaminationsinpatientswithdiabetesshouldincludetestingforperipheralneuropathyusingtheSemmes-Weinsteintest(grade1B).(3)Annualassessmentisrecommendedofpedalperfusionbyankle-brachialindex(ABI),ankleandpedalDopplerarterialwaveforms,andeithertoesystolicpressureortranscutaneousoxygenpressure(TcP O 2 )forpatientswithacurrentdiabeticfootulcer(DFU)(grade1B).(4)Adequateglycemiccontrol(hemoglobinA 1C <7%)shouldbeachievedtoreduceDFUsandinfectionswithsubsequentriskof amputation(grade2B).(5)RevascularizationbysurgicalbypassorendovasculartherapyisrecommendedforpatientswithDFUandperipheralarterialdisease(PAD)(grade1B).(6)ProphylacticarterialrevascularizationtopreventDFUsshouldnotbedone(grade1C). ClinicalReview&Education JAMAClinicalGuidelinesSynopsis  jama.com  (Reprinted) JAMA  October10,2017 Volume318,Number14  1387 © 2017 American Medical Association. All rights reserved. Downloaded From: by a University of Florida User on 10/19/2017  A TcP O 2  threshold of less than 30 mm Hg was predictive of com-plete ulcer healing (OR, 15.81; 95% CI, 3.36-74.45) and risk of amputation (OR, 4.14; 95% CI, 2.98-5.76). Six additional non-invasivetestsrevieweddidnothavesufficientpatientnumberstoperform appropriate meta-analysis. 7 To examine the large body of evidence that exists comparingintensive and less intensive glycemic control strategies and theireffect on preventing diabetic foot syndrome, the authors analyzed9randomizedtrialsenrolling10897patientswithdiabeteswithoutDFUs. 8 In these studies, intensive glucose control (hemoglobin A 1c 6%-7.5%) was associated with a significant decrease in risk of amputation(relativerisk[RR],0.65;95%CI,0.45-0.94)andslowerdecline in the sensory vibration threshold (mean difference,−8.27 μm; 95% CI, −9.75 μm to −6.79 μm) but not with ischemicchanges (development of gangrene, ischemic ulcer, new-onsetclaudication, or new diagnosis of PAD) (RR, 0.92; 95% CI, 0.67-1.26) or new-onset peripheral or autonomic neuropathy on annualexamination(RR,0.89;95%CI,0.75-1.05). 8 Apreviouslycommissionedsystematicreviewincluding49non-randomizedstudiesand8290patientswasusedtoanalyzetheef-fectiveness of revascularization in the setting of PAD and a DFU. 9 Openrevascularizationhadamedian2-yearlimbsalvagerateof85%(interquartile range, 80%-90%); the rate for endovascular inter-ventionwas78%(interquartilerange,70.5%-85.5%). 9 In7studiesreporting wound healing, more than 60% of ulcers healed follow-ingrevascularizationat1year. 9 Thereisinsufficienttrialevidencedemonstratinganyimprove-mentinDFUafterprophylacticrevascularization.Thehigherpreva-lenceoflong-segmentanddistalocclusivediseaseinpatientswithdiabetes,endothelialdamageinducedbyinterventions,andsignifi-cant perioperative complication risks associated with both endo-vascularandopenrevascularizationarecompellingreasonstopur-suenonoperativeapproachestoprevention. 3 BenefitsandHarms Thebenefitsofimprovingdiabeticfootcarearedecreasedratesof DFUsandtheirassociatedsequelaeofinfectionandamputation,out-comesassociatedwithimprovedphysicalandemotionalfunction-ingforpatients,improvedproductivity,anddecreasedtotalhealthcarecosts. 3 Preventivecareandnoninvasivetestinghavenoasso-ciatedharmsintrinsictothetests.False-positivetestresultsdooc-cur(thereisahighprevalenceofmedialcalcinosisinpatientswithdiabetes that may falsely elevate the ABI), and these are associ-atedwithincreasedcosts. 3 Discussion The prevalence of PAD among patients with diabetes is between10%and40%,andtheincidenceisincreasingworldwide. 3 Concor-dantly, an increasing proportion of DFUs have an ischemic compo-nent. Ischemic ulcers are associated with higher recurrence rates,higher amputation rates, and decreased levels of functional inde-pendence compared with neuropathic ulcers. 3 The guidelinesdirect special attention to this trend by recommending regularassessment for PAD as a component of preventative diabetic footcare in conjunction with optimal glycemic control. Comprehensivemultidisciplinary foot care at all stages of diabetic foot syndrome isessential to improve patient care and ultimately to reduce the sub-stantialburdenofthischallengingdisease. AreasinNeedofFutureStudyorOngoingResearch Thesystematicreviewsassociatedwiththisguidelineindicatedaneedforcomparativeeffectivenessresearchexaminingtheteststhatpre-dictwoundhealingaswellasthemethodsofdebridement.Similarly,severalofthesystematicreviewsrevealedapaucityofevidencere-garding effective interventions beyond hyperbaric oxygen therapyoroff-loadingmethodswiththerapeuticshoesandinsoles.Randomizedtrialscomparingendovascularandopenrevascu-larizationinpatientswithdiabetesacrossaspectrumofclinicalpre-sentationareneeded.Theguidelineacknowledgesthatbothtech-niquescurrentlyhaverolesinlimbsalvage,buttherearelimiteddataregardingwhichpatientsmaybenefitmorefromagivenapproach.Last, there is a significant need for updated cost-effectiveness re-search to identify best practices that may shape future policy andreimbursementforcareofdiabeticfootsyndrome. ARTICLEINFORMATION AuthorAffiliations: SectionofVascularSurgery,UniversityofChicago,Chicago,Illinois(Hart);DepartmentofSurgery,UniversityofChicago,Chicago,Illinois(Milner);SectionofGeneralInternalMedicine,UniversityofChicago,Chicago,Illinois(Cifu). CorrespondingAuthor: TheodoreHart,MD,UniversityofChicago,5841SMarylandAve,MC5030,Chicago,IL60637(theodore.hart@uchospitals.edu). SectionEditor: EdwardH.Livingston,MD,DeputyEditor,  JAMA . ConflictofInterestDisclosures: AllauthorshavecompletedandsubmittedtheICMJEFormforDisclosureofPotentialConflictsofInterest. REFERENCES 1 . InternationalDiabetesFederation. IDFDiabetes Atlas .7thed.http://www.diabetesatlas.org.AccessedJanuary1,2017. 2 . SinghN,ArmstrongDG,LipskyBA.Preventingfootulcersinpatientswithdiabetes.  JAMA .2005;293(2):217-228. 3 . HingoraniA,LaMuragliaGM,HenkeP,etal.Themanagementofdiabeticfoot:aclinicalpracticeguidelinebytheSocietyforVascularSurgeryincollaborationwiththeAmericanPodiatricMedicalAssociationandtheSocietyforVascularMedicine.  JVascSurg .2016;63(2)(suppl):3S-21S. 4 . DargisV,PantelejevaO,JonushaiteA,VileikyteL,BoultonAJ.BenefitsofamultidisciplinaryapproachinthemanagementofrecurrentdiabeticfootulcerationinLithuania:aprospectivestudy. DiabetesCare  .1999;22(9):1428-1431. 5 . CallaghanBC,PriceRS,FeldmanEL.Distalsymmetricpolyneuropathy:areview.  JAMA .2015;314(20):2172-2181. 6 . MayfieldJA,SugarmanJR.TheuseoftheSemmes-Weinsteinmonofilamentandotherthresholdtestsforpreventingfootulcerationandamputationinpersonswithdiabetes.  JFamPract  .2000;49(11)(suppl):S17-S29. 7 . WangZ,HasanR,FirwanaB,etal.Asystematicreviewandmeta-analysisofteststopredictwoundhealingindiabeticfoot.  JVascSurg .2016;63(2)(suppl):29S-36S. 8 . HasanR,FirwanaB,ElraiyahT,etal.Asystematicreviewandmeta-analysisofglycemiccontrolforthepreventionofdiabeticfootsyndrome.  JVascSurg .2016;63(2)(suppl):22S-28S. 9 . HinchliffeRJ,AndrosG,ApelqvistJ,etal.Asystematicreviewoftheeffectivenessof revascularizationoftheulceratedfootinpatientswithdiabetesandperipheralarterialdisease. DiabetesMetabResRev  .2012;28(suppl1):179-217. ClinicalReview&Education JAMAClinicalGuidelinesSynopsis 1388 JAMA  October10,2017 Volume318,Number14  (Reprinted)  jama.com © 2017 American Medical Association. All rights reserved. Downloaded From: by a University of Florida User on 10/19/2017
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