dynamed diabetic foot ulcer
DESCRIPTION
DM ulcerTRANSCRIPT
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Diabeticfootulcer
Updated2015Apr2303:58:00PM:honeydressingmayhavesimilarhealingratecomparedtosalineorpovidoneiodinedressinginpatientswithdiabeticfootulcer(CochraneDatabaseSystRev2015Mar6)viewupdate Showmoreupdates
RelatedSummaries:Diabetes(listoftopics)Diabetesmellitustype1Diabetesmellitustype2inadultsDiabeticneuropathyPhysicianQualityReportingSystemQualityMeasures
Description:
Types:
GeneralInformation
ulcerationinfootofpatientwithdiabetesulcermaybeduetoneuropathy,pressure,ischemia,orvenoushypertension(2)
presenceofulcerisamajorpredisposingfactorfordiabeticfootinfection,butdoesnotguaranteepresenceofinfection(1)
InfectiousDiseasesSocietyofAmerica(IDSA)andInternationalWorkingGroupontheDiabeticFootclinicalclassificationofdiabeticfootinfection(1)
IDSAclassification:Uninfected(PEDISgrade1)woundwithoutpurulenceoranyevidenceofinflammation(localswellingorinduration,erythema,localtendernessorpain,localwarmth)
IDSAclassification:Mildinfection(PEDISgrade2)localinfectionwithwoundlimitedtoskinorsuperficialsubcutaneoustissuewithpresenceof2signsofinflammation(purulence,erythema,painortenderness,warmth,orinduration)and,iferythema,mustbe>0.5cmto2cmaroundulcerexcludingothercausesofinflammatoryresponsesoftheskin(suchas,gout,Charcotneuoosteoarthropathy,fracture,thrombosis,orvenousstasis)
IDSAclassification:Moderateinfection(PEDISgrade3)localinfection(asabove)with>2cmofsurroundingerythemaorwoundinvolvingdeeperstructuresthanskinandsubcutaneoustissue(suchas,osteomyelitis,abscess,fasciitis,septicarthritis)intheabsenceofsystemicinflammatoryresponsesigns
IDSAclassification:Severeinfection(PEDISgrade4)localinfection(asabove)PLUSatleast2ofthefollowingsignsofsystemicinflammatoryresponsesyndrome
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Whoismostaffected:
Incidence/Prevalence:
Likelyriskfactors:
temperature>38degreesC(100.4degreesF)or90beats/minuterespiratoryrate>20breaths/minuteorPaCO 12,000or10yearsmalegenderHbA1c>9%ReferenceArchInternMed1998Jan26158(2):157 EBSCOhostFullTextfulltext
somediagnostictestsandphysicalsignsmaysuggestincreasedriskfordiabeticfootulcer
basedonsystematicreviewwithlimitedevidencesystematicreviewof11cohortand5casecontrolstudiesoftestsinpatientswith
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Factorsnotassociatedwithincreasedrisk:
type1ortype2diabetesandsubsequentincidenceoffootulcerationmethodologicqualitywaslimitedoverallwithonly2cohortstudieshavingassessmentblindedtotestbeingevaluatedfactorssignificantlyassociatedwithincreasedriskincluded
peakplantarpressure(6studies)vibrationperceptionthreshold(8studies)transcutaneousoxygentension30dayshistoryofrecurrentfootulcerstraumaticfootwoundperipheralvasculardiseaseinaffectedlimbpreviouslowerextremityamputationlossofprotectivesensationrenalinsufficiencyhistoryofwalkingbarefoot
weightbearingactivitynotassociatedwithincreasedriskweightbearingprogramnotassociatedwithincreaseinfootulcersamongpatientswithdiabeticperipheralneuropathy
basedonrandomizedtrialwithhighdropoutrate79patients>50yearsoldwithdiabeticperipheralneuropathyrandomizedtoweightbearingexercisevs.controlandfollowedfor12monthsweightbearingexercisegroupreceivedlegstrengtheningandbalanceexercises,selfmonitoredwalkingprogramandmotivationaltelephonecallsfromphysicaltherapistevery2weeksduringmonths412allpatientsreceiveddiabeticfootcareeducation,regularfootcareand8sessionswithaphysicaltherapist39%patientscompletedtrialnosignificantdifferenceinrateoffootulcersbetweengroupsReferencePhysTher2008Nov88(11):1385 EBSCOhostFullTextfulltext
dailyweightbearingactivitynotassociatedwithincreasedriskof
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Causes:
Pathogenesis:
History:
Chiefconcern(CC):
diabeticfootulcerbasedonprospectivecohortstudy400patientswithdiabetesandpriorfootulcerreporteddailyweightbearingactivityevery17weeksfor2yearsafteradjustmentforotherfactors,riskoffootulcercomparedtopatientswith5timesincreasedrateofcancerdeath,butinsufficientevidencetodetermineifincreasedrateofnewcancersnosingletypeofcancerimplicatedReferenceFDASafetyReview2008Mar27,FDASafetyReview2008Jun6FDAaddsBOXEDWARNINGonlabelofbecaplermin(Regranex)gel0.01%toreflectincreasedriskofcancermortalityinpatientsusing3tubes(FDAPressRelease2008Jun6)EuropeanMedicinesAgencyrecommendscontraindicationforRegranexinpatientswithanyformofcancer(EuropeanMedicinesAgencyPressRelease2010Feb18PDF)
becaplermin100mcg/ggelmayleadtofasterhealinginpatientswithdiabeteswithchronicneuropathiculcers(level2[midlevel]evidence)
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Antifungalagents:
basedonrandomizedtrialwithallocationconcealmentnotstated382patientswithdiabetesandchronicneuropathiculcers(meanarea2.7cm ,meanduration49weeks)randomizedtobecaplermingel100mcg/g(0.01%)vs.30mcg/g(0.003%)vs.placeboappliedtowoundoncedaily
2
patientsalsohadtissuedebridement,dailydressingchangesandtreatmentofinfectioncomparingbecaplermingel100mcg/gvs.30mcg/gvs.placebo
completehealingat20weeksin50%vs.36%vs.35%(p=0.007for100mcg/gvs.placebo)alltreatmentgroupshadabout30%ulcerrecurrenceratenosignificantadverseeffects
studyfundedbydrugmanufacturerReferenceDiabetesCare1998May21(5):822 EBSCOhostFullTextfulltext
becaplermingelmayimprovehealingofdiabeticulcersoflowerextremitiesbasedonrandomizedtrial118patientswithlowerextremitydiabeticulcersrandomizedtobecaplermingel0.003%vs.placebogelfor20weekscomparingbecaplerminvs.placebo
completehealingin48%vs.25%(p=0.01,NNT5)medianreductioninulcerarea98.8%vs.82.1%(p=0.09)nosignificantdifferencesintheincidenceorseverityofadverseevents
ReferenceJVascSurg1995Jan21(1):71additionofbecaplermingeltomoistureregulatingwounddressingnotassociatedwithstatisticallysignificantimprovementinfootulcerclosure(level2[midlevel]evidence)
basedonsmallrandomizedtrial32diabeticfootulcersrandomizedtobecaplermin0.01%gelvs.nogelallpatientreceivedmoistureregulatingwounddressing(TheraGauze)andtissuedebridementasneedednosignificantdifferencesinwoundclosureat
12weeks(46.2%inbothgroups)20weeks(69.2%withbecaplerminvs.61.5%withnogel)
woundclosurerate(nopvaluesreported)0.41cm /weekwithbecaplermininthistrial2
0.37cm /weekwithnogelinthistrial2
0.24cm /weekwithbecaplermin(historicaldata)2
0.18cm /weekwithsalinemoisteneddressings(historicaldata)2
ReferenceJAmPodiatrMedAssoc2010MayJun100(3):155notforuseinwoundsclosedbyprimaryintention,dosinginstructionsinvolvecalculationofamountofgelbasedonsizeofulcerandsizeoftube(MonthlyPrescribingReference1998Feb:A26)
additionoffluconazoletousualcaremayreducehealingtimefordiabeticfootulcerswithinvasiveinfection(level2[midlevel]evidence)
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Topicaltretinoin:
Lowmolecularweightheparins:
basedonrandomizedtrialwithoutblinding75patients(meanage59years)withfungalandbacterialinfectionsindeeptissuesoffootulcersrandomizedtofluconazole150mg/dayorallyinadditiontousualcarevs.usualcarealoneandfollowedfor34weeksoruntilwoundhealingusualcareincludedsurgicaldebridement,specificantibiotics,reducedweightonfoot,andglycemiccontrolwoundhealingdefinedascompleteepithelializationorskingraftingcomparingfluconazolevs.usualcare
meanwoundhealingtime7.3weeksvs.11.3weeks(p8yearsoldwithfootulcer>3monthsrandomizedtobemiparinvs.placebo
bemiparin3,500units/daygivenfor10daysfollowedby2,500units/dayfor3
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Granulocytecolonystimulatingfactor(GCSF):
Plateletrichplasmagel:
monthsbothgroupsreceivedusualcare
comparingbemiparinvs.placeboulcerimprovementbydigitalphotographyin70.3%vs.45.5%(p=0.035,NNT4,95%CIforNNT243)completehealingat3monthsin35.1%vs.33.3%(notsignificant)similarnumberofadverseeventsbetweengroups
ReferenceDiabetMed2008Sep25(9):1090 EBSCOhostFullText
GCSFmayreduceamputationriskinpatientswithdiabeticfootinfections(level2[midlevel]evidence)
basedonCochranereviewlimitedbyclinicalheterogeneitysystematicreviewof5randomizedtrialscomparingGCSFvs.placeboornoaddedgrowthfactor(control)in167patientswithdiabeticfootinfectionsallpatientsreceivedusualcarewithantibioticsclinicalheterogeneityoftrialsincluded
patientswithvaryingdegreesofinfectionseveritydifferencesinantibioticregimensdifferencesinGCSFpreparations,dosesanddurations
GCSFassociatedwithreducedrateofamputationinanalysisofalltrials
riskratio(RR)0.41(95%CI0.180.95)NNT7112with18%amputationrateincontrolgroup
reducedrateofanysurgicalinterventioninanalysisofalltrialsRR0.38(95%CI0.210.7)NNT410withsurgicalinterventionin35%ofcontrolgroup
nonsignificantimprovementininfectionstatus(RR1.29,95%CI0.991.67)inanalysisof4trialswith140patientsreducedhospitalstay(meandifference1.4days,95%CI2.27to0.53days)inanalysisof2trialswith50patients
nosignificantdifferencesinwoundhealing,durationofantibiotictreatment,andsideeffectsReferenceCochraneDatabaseSystRev2013Aug17(8):CD006810
plateletrichplasmagelassociatedwithincreasedwoundhealinginnonhealingdiabeticfootulcers(level2[midlevel]evidence)
basedonrandomizedtrialwithoutintentiontotreatanalysis72patientswithnonhealingdiabeticfootulcersrandomizedtoplateletrichplasmagelvs.salinegelandfollowedfor12weeksoruntilhealing32patients(44%)excludedfromfinalanalysiswoundhealedin81.3%withplateletrichplasmagelvs.42.1%withcontrolgel(p=0.036,NNT3)afteradjustmentplateletrichplasmagelassociatedwithshortertimetohealing(p=0.0177)ReferenceOstomyWoundManage2006Jun52(6):68
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Chinesemedicine:
plateletrichplasmagelreportedtoimprovehealingofnonhealingulcersin2caseseries(level3[lackingdirect]evidence)
caseseriesof17patients(aged4478years)withcutaneousulcers(4diabetic,11vascular,1posttraumatic,1decubitus)treatedwithplateletgel
completereepithelializationof4ulcers50%reductioninulcersizein11ulcersnoimprovementin2patientsReferenceBloodTransfus2010Oct8(4):237fulltext
caseseriesof49patients(meanage60.6years)with65nonhealingwoundstreatedwithautologousplateletrichplasmaformean3.2applicationsovermean2.8weeks
21werepressureulcers,16werevenousulcersand14diabeticfootulcers97%reportedsomeimprovementReferenceOstomyWoundManage2010Jun56(6):36
additionofChinesemedicinetostandardtherapymightimprovehealingrateindiabeticfootulcers(level2[midlevel]evidence)
basedonsystematicreviewof6lowqualityrandomizedtrialssystematicreviewof6randomizedtrialsevaluatingadditionofChinese(traditionalandherbal)medicineorallytostandardtherapyin439patientswithdiabeticfootulcersstandardtherapydefinedasantidiabetictreatmentwithorwithoutuseofantibiotics,debridementandosteomyelitistreatmentall6trialshadinadequatelydescribedallocationconcealmentandblindingofoutcomeassessorChinesemedicineassociatedwith
greaterulcerhealingrate(RR0.62,95%CI0.390.97)inanalysisof4trialswith286patientsgreaterrateof30%reductioninulcerarea(RR0.81,95%CI0.710.92)inanalysisof3trialswith224patientsfewerpatientswithoutanyimprovement(RR0.34,95%CI0.210.53)inanalysisof6trialswith439patients
adverseeventsincludednausea,epigastricpainanddrymouthReferenceJAlternComplementMed2010Aug16(8):889 EBSCOhostFullTextPDF
ChineseherbalmedicineTangzuYuyangointmentassociatedwithimprovementindiabeticfootulcers(level2[midlevel]evidence)
basedonsmallrandomizedtrial57patientswithchronicdiabeticfootulcersofWagner'sulcergrade13randomizedtotopicalTangzuYuyangointmentplusstandardwoundtherapyvs.standardwoundtherapyaloneandfollowedfor24weeks84%completedtrialcomparingTangzuYuyangointmentplusstandardwoundtherapyvs.standardwoundtherapyalone
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Herbaltreatments:
Othermedications:
Surgeryandprocedures:
ulcerimprovementat12weeksin79.2%vs.41.7%(p=0.017,NNT3)ulcerimprovementat24weeksin91.7%vs.62.5%(p=0.036,NNT4)
nosignificantdifferenceinnumberofulcerscompletelyhealedat4,12,and24weeks,adverseevents,orhealingtimeReferenceJEthnopharmacol2011Jan27133(2):543
Pycnogenolmayimprovesymptomsandhealingrateinpatientswithdiabeticfootulcer(level2[midlevel]evidence)
basedonsmallrandomizedtrial30patientswithdiabeticfootulcerrandomizedto1of4groups
oralPycnogenolpluslocalPycnogenol(combination)localPycnogenolonlyoralPycnogenolonlystandardcare
meanmicrocirculatorysymptomscore(scale010,with0indicatingnosymptoms)2.2pointsincombinationgroup(p
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InfectiousDiseasesSocietyofAmerica(IDSA)recommendations(1)
nonsurgicalcliniciansshouldconsiderassessmentbysurgeonforpatientswithmoderateorseverediabeticfootinfection(IDSAWeakrecommendation,Lowqualityevidence)involvevascularsurgeonearlywheneverischemiacomplicatesdiabeticfootinfection,especiallyinpatientwithcriticallyischemiclimb(IDSAStrongrecommendation,Moderatequalityevidence)refertosurgeonexperiencedwithdiabeticfootinfectionsandadequateknowledgeoffootanatomyifpatientrequirescomplexorreconstructiveprocedures(IDSAStrongrecommendation,Lowqualityevidence)
urgentsurgeryneededformostfootinfectionsaccompaniedbygasinthedeepertissues,abscess,ornecrotizingfasciitis(IDSAStrongrecommendation,Lowqualityevidence)lessurgentsurgeryneededforwoundswithsubstantialnonviabletissueorextensiveboneorjointinvolvement(IDSAStrongrecommendation,Lowqualityevidence)surgicaldebridementincludinglimitedresectionsoramputationsmayreduceneedformoreextensiveamputationssurgicalapproachshouldoptimizelikelihoodforhealingandattempttopreserveintegrityofwalkingsurfaceoffoot
debridedevitalizedandnecrotictissuetodecreasebacterialloadofwoundandpromotewoundhealing(2)
decreasebacterialcontaminationofwoundpriortoattemptingsurgicalclosurewithskingrafting(2)
surgicaldebridementisalsonecessaryforosteomyelitis,earlyandaggressivedrainageanddebridementisnecessaryforlimbthreateninginfectionsamputationmaybenecessarytocontrolsepsisskinreplacementtherapies
skinreplacementtherapiesmightbeeffectivefordiabeticfootulcer(level2[midlevel]evidence)
basedonsystematicreviewofrandomizedtrialswithmethodologicallimitationssystematicreviewof5randomizedtrialscomparingdermalallografts,bioengineeredskingraftsordermalandepidermalautograftstostandardcarefordiabeticfootulcerin792patientsmethodologicallimitationsincluded
allocationconcealmentnotreportedlackofintentiontotreatanalysislackofblindedoutcomeassessment
completeulcerclosurein43.3%forgraftgroupsvs.29.3%forcontrolgroups(p
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Lasertherapy:
basedonpooledanalysisof2randomizedtrialswithoutblinding280patientswithnoninfecteddiabeticfootulcersfor2weekswhowererandomizedtoApligraf(bilayeredcelltherapy)vs.noadditionaltreatmentwereanalyzedallpatientsreceivedstandardtherapy(sharpdebridement,standardwoundcare,andoffloading)competewoundclosurein55.2%ofApligrafpatientsvs.34.4%ofcontrolpatientsby12weeks(p=0.0005,NNT5)ReferenceJAmPodiatrMedAssoc2010JanFeb100(1):73
Achillestendonlengtheningreducesrecurrenceratesfordiabeticfootulcer(level1[likelyreliable]evidence)
basedonrandomizedtrial64patientswithdiabetesmellitusandneuropathicplantarulcerwererandomizedtototalcontactcastpluspercutaneousAchillestendonlengtheningvs.totalcontactcastalonecomparingAchillestendonlengtheningvs.totalcontactcastalone
healingrates100%vs.88%(notsignificant)meanhealingtime58daysvs.41days(notsignificant)ulcerrecurrencewithin7monthsin15%vs.59%(p=0.001,NNT3)ulcerrecurrencewithin2yearsin38%vs.81%(p=0.002,NNT3)
ReferenceJBoneJointSurgAm2003Aug85A(8):1436 EBSCOhostFullTextnoadditionaltrialsfoundinCochraneDatabaseSystRev2013Jan31(1):CD002302
selectiveplantarfasciareleasereportedtoimprovehealingofforefootulcersinpatientswithdiabetes(level3[lackingdirect]evidence)
basedoncaseseries60patientswithdiabetesandforefootulcerfor>3monthsandperipheralneuropathyandnoevidenceofinfectionhadselectiveplantarfasciarelease(SPFR)procedureSPFRtransectsfibersofplantarfascia(alsocalledplantaraponeurosis)thatinsertintoaffectedtoehealingofulcerin
40patientsoverall(67%)bysixweeks7of16(44%)ulcersatmetatarsophalangeal(MTP)joint29of48(60%)ulcersonplantartoe
healingassociatedwithpreoperativedorsiflexionanglebetween5and30(p12%)inadequatelowerextremityperfusionulcertreatmentwithnormothermicorHBOtherapyconcomitantmedicationssuchascorticosteroids,immunosuppressivemedicationsorchemotherapy
allpatientshadstandardoffloadingasneeded335patients(98%)whohadallocatedtreatmentincludedinmodifiedintentiontotreatpopulationcomparingnegativepressurewoundtherapyvs.advancedmoistwoundtherapy
completewoundclosurein43.2%vs.28.9%(p=0.007,NNT7)at112daysfollowupestimatedmediantimetocompletewoundclosurewas96daysforvs.undeterminedfor(p=0.001)secondaryamputationsin4.1%vs.10.2%(p=0.035,NNT17)at6months
nosignificantdifferencesininfections,cellulitisorosteomyelitisat6monthsReferenceDiabetesCare2008Apr31(4):631 EBSCOhostFullTextfulltext,commentarycanbefoundinDiabetesCare2008Oct31(10):e76andEvidBasedNurs2008Oct11(4):116
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Lighttherapy:
Autologousplateletrichplasma:
negativepressurewoundtherapyforpartialfootamputationwoundmayimprovehealingandpreventsecondamputation(level2[midlevel]evidence)
basedonrandomizedtrialwithhighdropoutrate162adultswithpartialdiabeticfootamputationwoundsuptotransmetatarsallevelandadequateperfusionwererandomizedtonegativepressurewoundtherapy(usingvacuumassistedclosuretherapysystem,dressingchangesevery48hours)vs.standardmoistwoundcare(dressingchangeseverydayoratphysiciandiscretion)untilhealingor112days(16weeks)comparingnegativepressurewoundtherapyvs.standardmoistwoundcare
healingin56%vs.39%(p=0.04,NNT6)completewoundclosurewithoutsurgicalinterventionin40%vs.29%22%vs.25%withdrewbeforelasttreatmentvisitwithoutwoundclosuresecondamputationin3%vs.11%(p=0.06)negativepressurewoundtherapyassociatedwithfasterrateofwoundhealing
nosignificantdifferencesinadverseeventscomparinginterventionvs.control52%vs.54%oneormoreadverseevents17%vs.6%adverseeventofwoundinfection12%vs.13%treatmentrelatedadverseevent
ReferenceLancet2005Nov12366(9498):1704 EBSCOhostFullText,commentarycanbefoundinLancet2006Mar4367(9512):725EBSCOhostFullText
visiblelighttherapymightimprovehealingofdiabeticorvenousfootulcers(level2[midlevel]evidence)
basedonsmallcontrolledtrial16patientswithdiabeticfootulcersorchroniclegulcerstreatedwithbroadbandlightsource(400800nm)attherapeuticdose(180mW/cm )vs.placebodose(10mW/cm )twicedailyfor4minutes/session
2
2
at12weeks,completewoundhealingoccurredin9of10(90%)lighttherapypatientsvs.2of6(33%)controlpatients(NNT2)ReferencePhotomedLaserSurg2011Jun29(6):399
autologousplateletrichplasmanotassociatedwithincreasedwoundhealinginadultswithchronicwounds(level2[midlevel]evidence)
basedonCochranereviewoftrialswithmethodologiclimitationssystematicreviewof9randomizedtrialsevaluatingautologousplateletrichplasmain325adultswithchronicwoundsalltrialshad1limitationincluding
allocationconcealmentnotstatedhighlosstofollowuplackoforunclearblindingsmallsamplesize
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FootwearandCasting:
trialsevaluateddiabeticfootulcer(2trials),venouslegulcer(3trials),andmixedchronicwounds(4trials)comparingautologousplateletrichplasmatostandardtreatment(withorwithoutplacebo),nosignificantdifferencesin
completelyhealedwoundinanalysisof7trialswith274adultstotalareaepithelializedinanalysisof3trialswith66adultswoundcomplicationsinanalysisof3trialswith117adults
comparingautologousplateletrichplasmavs.biomaterialin1trialwith34adults,nosignificantdifferenceincompletewoundhealingReferenceCochraneDatabaseSystRev2012Oct17(10):CD006899
offloadpressureoverareaofulcerwithanyof(2)
crutcheswalkerwheelchairspecialshoescustominsertstotalcontactcast
allowscontinuedambulationwhilerelievingpressureatulcersitenotforusewithischemicorinfectedulcersminimalpadding,mostlyfoamaroundforefootmoldedtoshapeoffootandlegrubberheelundermidfootforwalkingremove2448hoursafterapplicationtoassessfit,thenchangecasteveryweekhealinggenerallytakes810weeksslowtransitionfromcasttoshoe,withinterimuseofsandalwiththick,pliantinsoleapplicationoftotalcontactcast
followingdebridementofulceranddrysteriledressinggenerallyrequires2peopleand30minutesfirstruleoutosteomyelitisoruncontrolledinfection
keepfeetclean,butheat,soaksandwhirlpooltherapymaydamagetissueandpromoteinfectionnonremovablepressurerelievingcastsassociatedwithimprovedulcerhealingandmaybemoreeffectivethanremovablepressurerelievingdevicesinadultswithdiabeticfootulcer(level2[midlevel]evidence)
basedonCochranereviewoftrialswithmethodologiclimitationssystematicreviewof14randomizedtrialsevaluatingpressurerelievinginterventionsin709adultswithdiabeticfootulceralltrialshad1limitationincluding
unclearallocationconcealmentlackoforunclearblindingofoutcomeassessorslackofintentiontotreatanalysissmallsamplesize
nonremovablecastassociatedwithincreaseinhealedulcerscomparedto
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Followup:
Complications:
Prognosis:
Woundhealing:
removablecastinanalysisof5trialswith230adultsriskratio1.17(95%CI1.011.36)NNT5150withhealedulcersin67%ofremovablecastgroup
nonremovablecastsignificantlyincreasedulcerhealingvs.dressingalonein2trialswith98adultsfeltfittedtotemporarytherapeuticshoehadborderlinesignificantincreaseinulcerhealingat14weeksvs.feltfittedtofootin1trialwith32adultsnosignificantdifferenceinulcerhealingcomparing
standardnonremovabletotalcontactcastvs.instanttotalcontactcast(removablecastwalkerplusfiberglasscastingmaterial)in1trialwith41adultsremovablecastwalkervs.removablehalfshoein1trialwith50adultstemporarytherapeutichalfshoevs.feltedfoamdressingin1trialwith61adults
ReferenceCochraneDatabaseSystRev2013Jan31(1):CD002302fulltext
priortohospitaldischarge,confirmpatientisclinicallystableandhas(IDSAStrongrecommendation,Lowqualityevidence)(1)
hadanyurgentlyneededsurgeryachievedacceptableglycemiccontrolabilitytomanage(onhis/herownorwithhelp)atdesignateddischargelocationappropriateantibioticregimentowhichpatientwilladhereoffloading(ifneeded)andspecificwoundcareregimensplanforappropriateoutpatientfollowup
reviewofcareofelderlypatientwithlowerextremityamputationcanbefoundinJAmBoardFamPract2000JanFeb13(1):23
ComplicationsandPrognosis
osteomyelitisispotentialcomplicationofanyinfected,deep,orlargefootulcer,especiallyifchronicoroverlyingbonyprominence(1)
sepsisamputation
47%rateofhealingwithin20weeks,morelikelyifsmallwoundofshortduration(level2[midlevel]evidence)
basedonretrospectivecohortstudyrecordsreviewedof27,630patientswithdiabeticneuropathicfootulcersinalargewoundcaresystem12,983(47%)achievedhealingwithin20weeksofcaresimplestprognosticmodelgave1pointforeachof
woundolderthan2monthswoundlargerthan2cm2
grade3on6pointwoundassessmentscale
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likelihoodofwoundhealingby20weeks65%forscoreof053%forscoreof134%forscoreof229%forscoreof3
ReferenceAmJMed2003Dec1115(8):62722%42%healingratesat20weekswithstandardcareregimensdependingonwoundsizeandduration(level2[midlevel]evidence)
basedonmetaanalysismetaanalysisofindividualdataof586patientswithdiabetesandneuropathicfootulcerinstandardcarearmsof5randomizedtrialsallreceived"goodwoundcare,"debridementand"offloading"ofwoundhealingwithin20weekswasmorelikelyifsmallwound,woundofshorterdurationandnonwhiteracehealingratesat12weeksbasedonwoundsizeandduration
woundsize4cm 13.8%2
woundduration12months15.3%woundduration
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Amputationrisk:
ReferenceDiabetesCare2007Aug30(8):2064 EBSCOhostFullTextfulltextposteriortibialpulsebyDopplerexamandpainlessulcerappeartopredictwoundhealing(level2[midlevel]evidence)
basedonsmallcohortstudycohortstudyof64consecutivepatientswithdiabeteswith78footulcers47%healedby6monthfollowuppredictorsoffailuretohealwereabsentposteriortibialpulsebyDopplerexam(oddsratio[OR]8.5)andpainatulcersite(OR3.7)inabsenceofDopplerexam,predictorsofpooroutcomewerepreviousamputationandpainatulcersitemagneticresonanceimaging(MRI)diagnosisofosteomyelitisdidnotpredictfailuretoheal,butonly42patientshadinterpretableMRIReferenceJGenInternMed1997Sep12(9):537fulltext
signssuggestingpossibleimminentlimbthreateninginfectioninclude(1)
rapidprogressionofinfectionextensivenecrosisorgangreneextensiveecchymosesorpetechiaebullae,especiallyhemorrhagicnewonsetwoundanesthesiacriticallimbischemia(decreasingerythema,warmthandinduration)extensivesofttissuelossextensivebonydestruction,especiallymidfoot/hindfootinclinicalsettingwithlessadvancedhealthcareavailable,lesserdegreeofinfectionseveritymayresultinlimbthreateninginfection
riskscorepredictsriskforlowerextremityamputationinpatientswithdiabeticfootinfection(level1[likelyreliable]evidence)
basedonderivationandvalidationcohortstudy2,230patientshospitalizedforculturedocumenteddiabeticfootinfectionwereinderivationcohortand788similarpatientswereinvalidationcohort463(20.8%)patientsinderivationcohortand183(23.2%)patientsinvalidationcohorthadlowerextremityamputationriskfactorsidentifiedinderivationcohortandpointsassignedtoderiveriskscore(totalscore055points)
chronicrenaldiseaseorcreatinine>3mg/dL(265.2mcmol/L)(1point)malegender(1point)temperature38degreesC(100.5degreesF)(2points)age50years(4points)infectedulcer(4points)historyofamputation(4points)albumin11,000/mm (7points)3
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Mortality:
Prevention:
surgicalsiteinfection(10points)transferredfromotheracutecarefacility(12points)
observedlowerextremityamputationrates
Results:
RiskScore DerivationCohort ValidationCohort
0points 0% 0%
14points 4.2% 5.7%
511points 10.7% 11.9%
1220points 25.9% 29.3%
21points 48.6% 49.2%
ReferenceDiabetesCare2011Aug34(8):1695 EBSCOhostFullTextfulltextposttreatmentCreactiveprotein(CRP)levelsmaypredictamputationriskinpatientswithinfecteddiabeticfootulcer(level2[midlevel]evidence)
basedonderivationcohortstudywithoutvalidationcohortprospectivestudyof201patientshospitalizedforinfecteddiabeticfootulcerandfollowedfor6months36patientswithoutregularfollowupvisitswereexcludedfromanalysisof165patientsanalyzed,70(42%)hadamputationforpredictingamputation
posttreatmentCRP30mg/dLhad65%positivepredictivevalueand76%negativepredictivevalueposttreatmentCRP50mg/dLhad71%positivepredictivevalueand73%negativepredictivevalueposttreatmentCRP90mg/dLhad83%positivepredictivevalueand68%negativepredictivevalue
ReferenceJAmPodiatrMedAssoc2011JanFeb101(1):1
diabeticfootulcerassociatedwithincreasedriskofdeathbasedonsystematicreviewof8studiesevaluatingassociationbetweendiabeticfootulcersandmortalityinpatientswithdiabetes3,619deathsoccurredduring81,116personyearsoffollowupcomparedtonodiabeticfootulcer,diabeticfootulcerassociatedwithincreasedriskof
allcausemortality(riskratio[RR]1.89,95%CI1.62.23)fatalmyocardialinfarction(RR2.22,95%CI1.094.53)fatalstroke(RR1.41,95%CI0.613.24)
ReferenceDiabetologia2012Nov55(11):2906 EBSCOhostFullText
PreventionandScreening
AmericanDiabetesAssociation(ADA)footcarerecommendations
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performannualcomprehensivefootexaminallpatientswithdiabetes,including(ADAGradeB)
inspectionofskinintegrityandmusculoskeletaldeformitiesassessmentoffootpulsestestingforlossofprotectivesensation(LOPS)withanyof
10gmonofilamentvibrationthresholdusing128hertz(Hz)tuningforkpinpricksensationanklereflexesvibrationthresholdusingbiothesiometer
patientswithinsensatefeet,footdeformities,andulcersshouldhavefootexamateveryvisit(ADAGradeE)providegeneralfootselfcareeducationtoallpatientswithdiabetes(ADAGradeB)
handoutondiabeticfootcarefromAmericanAcademyofFamilyPhysiciansorinSpanish
multidisciplinaryapproachrecommendedforindividualswithfootulcersandhighriskfeet(suchasdialysispatientsorpatientswithCharcotfoot,priorulcers,oramputation)(ADAGradeB)refertofootcarespecialistforongoingpreventivecareandlifelongsurveillanceforpatientswho(ADAGradeC)
smokehaveLOPShavestructuralabnormalitieshavehistoryofpriorlowerextremitycomplications
initialscreeningforperipheralarterialdisease(PAD)shouldinclude(ADAGradeC)historyforclaudicationassessmentofpedalpulses
ifpositiveanklebrachialindexorsignificantclaudication,referforfurthervascularassessmentandconsiderexercise,medications,andsurgicaloptions(ADAGradeC)forpatientswithneuropathyorevidenceofincreasedplantarpressure(suchaserythema,warmth,callus,ormeasuredpressure)
advisefootwearthatcushionsandredistributespressurecalluscanbedebridedwithscalpelbyfootcarespecialistorotherhealthprofessionalwithexperienceandtraininginfootcarepatientswithbonydeformities(suchashammertoes,prominentmetatarsalheads,orbunions)mayneedextrawideshoesorextradepthshoespatientswithextremebonydeformities(suchasCharcotfoot)mayneedcustommoldedshoes
patientswithdiabetesandhighriskfootconditionsshouldbeeducatedregardingtheirriskfactorsandappropriatemanagement,including
implicationsofLOPSimportanceofdailyfootmonitoring(visualinspectionorhandpalpationifneuropathy)properfootcare(includingnailandskincareandselectionofappropriate
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footwear)patientswithvisualdifficulties,physicalconstraints,orcognitiveproblemsthatlimitabilitytoassessfootstatusandrespondappropriatelywillneedotherpeopletohelpwiththeircareReferenceADApositionstatementonstandardsofmedicalcareindiabetes:microvascularcomplicationsandfootcare(DiabetesCare2015Jan38Suppl1:S58 EBSCOhostFullTextfulltext)
additionalADArecommendationsonpreventivefootcarepatientswithdiabeticneuropathyshouldhavevisualinspectionoftheirfeetateveryvisitwithahealthcareproviderpatientswith1highriskfootconditionsshouldbeevaluatedmorefrequentlythanannuallypatientswithneuropathyshouldbreakinnewshoesgraduallytominimizeformationofblistersandulcersReferenceADA2004policystatementonpreventivefootcareindiabetes(DiabetesCare2004Jan27Suppl1:S63 EBSCOhostFullTextfulltext)
limitedandinconsistentevidenceforinterventionstopreventdiabeticfootulcers
basedonsystematicreviewof12randomizedtrialsevaluatinginterventionsforpreventionofdiabeticfootulcerssurgicalbonedebridementandAchillestendonlengtheningreducedfootulcersinindividualpoorqualitytrialsinconsistentevidenceforpatienteducation(4trials)andtherapeuticfootwearorinsoles(3trials)plantarfoottemperatureguidedavoidancetherapyassociatedwithreduceddiabeticfootulcersininsensatefeetin3trials(2trialsdescribedbelow)ReferenceDiabetesCare2011Apr34(4):1041 EBSCOhostFullTextfulltext
possiblyeffectiveclinicalinterventionsforpreventingfootulcersinpatientswithdiabetes
educatingpatientsaboutproperfootcareperiodicfootexaminationsoptimizingglycemiccontrolsmokingcessationintensivepodiatriccaredebridementofcallusescertaintypesofprophylacticfootsurgeryReferencebasedonsystematicreviewwith22randomizedtrials(JAMA2005Jan12293(2):217 EBSCOhostFullTextfulltext)
patienteducationforpreventingdiabeticfootulcershaslimitedandconflictingevidence
basedonCochranereviewsystematicreviewof12randomizedtrialsevaluatingpatienteducationforpreventingdiabeticfootulcersinadultswithtype1ortype2diabetesmedianfollowup6months(range4weeksto7years)
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metaanalysisprecludedbyheterogeneityininterventionsandoutcomemeasuresfewtrialsreportedclinicalendpointsmixedresultscomparingintensivevs.briefeducationalinterventions
grouppatienteducationsession(1hour)pluspatientinstructionsonfootcaresignificantlyreducedfootulcerincidenceandamputationrateat1yearvs.routinepatienteducationin1trialwith182adults(354limbs)nosignificantdifferencesinfootulcerincidenceandamputationrateat1yearcomparingsingle1hourhomefootcareeducationsessionplustelephonefollowupandhandoutvs.handoutalonein1trialwith172adultsadditionof4weeklygroupeducationsessionstogrouppatienteducationprogram(14hoursover3days)significantlyreducedfootproblemsrequiringtreatmentat1month,butnosignificantdifferenceat6monthsin1trialwith70adults
nosignificantdifferenceinseverefootlesions(ulcers,amputations)at1.5yearscomparingfootcareeducationaspartofgeneraldiabeteseducationprogramvs.usualcarein1trialwith266adultsReferenceCochraneDatabaseSystRev2014Dec16(12):CD001488
foottemperaturemonitoringmayreducediabeticfootulcersinhighriskpatients(level2[midlevel]evidence)
basedonsystematicreviewwithoutassessmentofstudyqualitysystematicreviewof9studies(3randomizedtrialsand6observationalstudies)evaluatingtemperaturemonitoringinpredictionandpreventionofdiabeticfootulcerinpatientswithdiabetes3preventiontrialsincluded,2summarizedbelowfoottemperaturemonitoringassociatedwithincreasedpreventionofdiabeticfootulcersinanalysisof3randomizedtrials(oddsratio3.84,95%CI1.56.17),resultslimitedbysignificantheterogeneityReferenceJFootAnkleRes2013Aug76(1):31fulltextdermalthermometrywasuseofinfraredskintemperaturemeasurementson6sitesonsolesofeachfoottwicedailythermometerusedwasTempTouchthermometer(XilasMedicalIncorporated)
footwearorthosesadjustedforshapeandplantarpressuremaydecreaseriskofrecurrentplantardiabeticfootulcercomparedtostandardorthosesinadults(level2[midlevel]evidence)
basedonrandomizedtrialwithoutintentiontotreatanalysis150adults(meanage60years)withdiabetesandpriorfootulcerwererandomizedtoorthosesadjustedforshapeandplantarpressurevs.standardorthosesandfollowedupto16.5monthsadjustedorthosesmodifiedusingcomputeraideddesignprocessbasedonpeakbarefootplantarpressuredistributioncontours87%receivedfootwearandwereincludedinanalysescomparingadjustedvs.standardorthoses
plantarulcerrecurrencein9.1%vs.25%(p=0.007,NNT7)
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plantarulcerornonulcerativelesionin37.5%vs.45.3%(notsignificant)ReferenceDiabetesCare2014Jul37(7):1982 EBSCOhostFullText
custommadefootwearmightdecreaseriskofdiabeticfootulcerrecurrenceinpatientswithgoodadherence(level2[midlevel]evidence)
basedonsubgroupanalysisfromrandomizedtrialwithlowadherence171patientswithdiabetesandrecentlyhealedplantarfootulcerrandomizedtocustommadefootwearwith20%peakpressurereliefvs.nonimprovedfootwear(control)for18monthsadherence(definedas%stepsinfootwear)70.2%incustommadefootweargroupvs.75.5%incontrolgroup(notsignificant)comparingcustommadefootwearvs.control,footulcerrecurrencein
38.8%vs.44.2%(notsignificant)overall25.7%vs.47.8%(p=0.045,NNT5)inprespecifiedsubgroupanalysisof79patientswith80%adherence
ReferenceDiabetesCare2013Dec36(12):4109 EBSCOhostFullTexttherapeuticfootwearnotshowntopreventfootulcersinpatientswithdiabeteswithhistoryoffootulcer
basedonrandomizedtrial400patientswithdiabeteswithhistoryoffootulcerwhodidnotrequirecustomshoesforfootdeformitywererandomizedto1of3groups
3pairsoftherapeuticshoesandcustomizedmediumdensitycorkinsertswithneopreneclosedcellcover3pairsoftherapeuticshoesandprefabricatedtaperedpolyurethaneinsertswithbrushednyloncoverusualfootwear
2yearcumulativereulcerationratewas14%15%intreatmentgroupsand17%incontrolsbutdifferencesnotstatisticallysignificant88%100%ulcersoccurredinpatientswithfootinsensitivitysubjectshadcloseattentiontofootcarebyhealthcareproviders,soresultsmaynotapplytopatientswithlessattentivecareReferenceJAMA2002May15287(19):2552 EBSCOhostFullTextfulltextcommentarynotingthathalfthesubjectshadintactprotectivesensationandothercriticismscanbefoundinJAMA2002Sep11288(10):1231
insufficientevidencetosupportcomplexinterventionsforpreventionofdiabeticfootulceration
basedonCochranereviewsystematicreviewof5lowqualityrandomizedtrialsevaluatingcomplexinterventionsforpreventionoffootulcersinpatientswithdiabetescomplexinterventiondefinedasintegratedcareapproach,combining2preventionstrategieson2differentlevelsofcare(patient,healthcareproviderand/orthestructureofhealthcare)comparingintensivecomprehensiveinterventionvs.usualcare
nosignificantdifferencebetweengroupsinfootulcersat2yearsin1trialwith2,001patients
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Screening:
lowerextremityamputationsin0.7%vs.2.3%(p=0.0056,NNT65)at2yearsin1trialwith2,001patientssignificantimprovementinvariousselfcarebehaviorsat12monthswithcomprehensiveinterventionin1trialwith83patients
littleevidenceofbenefitin3trialscomparingeducationcenteredinterventionvs.usualcareorwritteninstructionsonlyReferenceCochraneDatabaseSystRev2010Jan20(1):CD007610(reviewupdated2011Oct5)
implementationofguidelines(StagedDiabetesManagement)byprimarycareprovidersassociatedwithdecreasedratesoflowerextremityamputation(level2[midlevel]evidence)
basedonbeforeandafterobservationalstudyin639AmericanIndianswithdiabetesinruralprimarycareclinicReferenceJFamPract1998Aug47(2):127
editorialdiscussionfocusingonlackofsupportingevidenceforstrategiesofpreventionofdiabeticfootulcercanbefoundinBMJ2008Sep3337:a1234 EBSCOhostFullText
screeningfordiabeticperipheralneuropathyAmericanDiabetesAssociation(ADA)recommendations
neuropathyscreeningscreenallpatientsfordiabeticperipheralneuropathystartingatdiagnosisoftype2diabetesand5yearsafterdiagnosisoftype1diabetesandatleastannuallythereafter,usingsimpleclinicaltests(ADAGradeB)electrophysiologicaltestingorreferraltoneurologistrarelyneeded,exceptinsituationswithatypicalclinicalfeaturesscreenforsignsandsymptomsofcardiovascularautonomicneuropathyinpatientswithmoreadvanceddisease(ADAGradeE)
footcareforallpatientswithdiabetes,performannualcomprehensivefootexaminationincluding(ADAGradeB)
inspectionofskinintegrityandmusculoskeletaldeformitiesassessmentoffootpulsestestingforlossofprotectivesensationwithanyof
10gmonofilamentvibrationusing12hertz(Hz)tuningforkpinpricksensationanklereflexesvibrationperceptionthresholdusingbiothesiometer
initialscreeningforperipheralarterialdiseaseshouldincludehistoryforclaudication,assessmentofpedalpulses,andconsideringanklebrachialindex(ABI)(ADAGradeC)
ReferenceADApositionstatementonstandardsofmedicalcareindiabetes:microvascularcomplicationsandfootcare(DiabetesCare2015Jan38Suppl:S58
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EBSCOhostFullTextfulltext)positiveSemmesWeinsteinmonofilamentexamappearstohavegoodpositivepredictivevaluefordetectionofdiabeticperipheralneuropathy(level2[midlevel]evidence)
basedonsystematicreviewofstudiesofvaryingqualitysystematicreviewof30studiesevaluatingSemmesWeinsteinmonofilamentexam(SWME)fordetectionofdiabeticperipheralneuropathywith8,365patientsstudiesusedwiderangeofmonofilamentsizes,numberandsitesoftestinglocations,diagnosticthresholds,andreferencetestsreferencetestsincluded
nerveconductionstudyhistoryofulcerationSanAntonioConsensusEvaluationvibrationthresholdwithbiothesiometerdetailedneurologicalassessmentHoffmanreflextest
diagnosticperformanceofmonofilamentexamcomparedtonerveconduction(referencestandard)in4studieswith1,065patients
rangeofsensitivity57%93%rangeofspecificity75%100%rangeofpositivepredictivevalue(PPV)84%100%rangeofnegativepredictivevalue(NPV)36%94%
thoughnotdirectlystudied,theauthorsrecommendtestingplantaraspectsofgreattoeandthirdandfifthmetatarsalheadstomaximizediagnosticvalueReferenceJVascSurg2009Sep50(3):675fulltextsimilarfindingsinadditionalsystematicreviewofmonofilamenttesting
basedonsystematicreviewwithheterogeneitysystematicreviewof3studiesofaccuracyof5.07/10gmonofilamentindetectionofperipheralneuropathyofanycauseusingnerveconductionasreferencestandardin641patientsstudiesappearedlimitedtopatientswithdiabetesmellitussensitivityrangedfrom41%to93%andspecificityrangedfrom68%to100%metaanalysiscouldnotbeconductedduetoheterogeneityReferenceAnnFamMed2009NovDec7(6):555 EBSCOhostFullTextfulltext
SWMEmaypredictriskoffootulcerationandamputationinpatientswithdiabetesmellitus(level2[midlevel]evidence)
basedonsystematicreviewwithheterogeneityandincompletereportingofstudyqualitysystematicreviewof9studiesevaluatingSWMEin11,007patientswithdiabetesmellitusanddataonulcerationorlowerextremityamputationinpatientswithnegativeandpositiveSWMEresultsallstudiesreportedtohavequalitylevelof2borhigherusingOxfordCenterforEvidenceBasedMedicinelevelsofevidence,butindividualstudyqualityor
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limitationsnotreporteddiabeticfootulcerationevaluatedin7studieswith10,029patientsfollowedfor14years
followuprangedfrom1to4yearsabsoluteriskofulcerationforpatientswithpositiveSWMErangedfrom12.4%to38.6%absoluteriskofulcerationforpatientswithnegativeSWMErangedfrom2.5%to10.7%relativeriskrangedfrom2.5(95%CI23.2)to7.9(95%CI4.414.3)
lowerextremityamputationsevaluatedin3studieswith1,336patientsfollowedfor1.53.3years
followuprangedfrom1.5to3.3yearsabsoluteriskoflowerextremityamputationforpatientswithpositiveSWMErangedfrom6.4%to35.3%absoluteriskoflowerextremityamputationforpatientswithnegativeSWMErangedfrom1%to21.4%relativeriskrangedfrom1.7(95%CI1.12.6)to15.1(95%CI4.352.6)
ReferenceJVascSurg2011Jan53(1):2204cmof25lbfishingline(homemade10gmonofilament)maybeeffectiveforscreeningfordiabeticneuropathy(level2[midlevel]evidence)
basedondiagnosticcasecontrolstudy579normalcontrolsand292patientswithdiabeticneuropathyevaluateddiagnosticperformanceof4cmof25lbfishingline(equivalentto10gmonofilament)
43%sensitivity99.3%specificity98.7%PPV(assuming55%prevalenceofneuropathy)59%NPV(assuming55%prevalenceofneuropathy)
diagnosticperformanceof8cmof25lbfishingline(equivalentto1gmonofilament)
52%sensitivity96.3%specificity94.6%PPV(assuming55%prevalenceofneuropathy)62%NPV(assuming55%prevalenceofneuropathy)
ReferenceJFamPract2006Jun55(6):505 EBSCOhostFullTextvibrationtestingwithonoffmethodisspecificfordiabeticperipheralneuropathy(level1[likelyreliable]evidence)
basedondiagnosticcohortstudy478patientsindiabetesclinichadblindedevaluationwith4tests
5.07/10gSWME(4timesondorsumofeachgreattoe)superficialpainsensation(4timesoneachfoot)vibrationtestingbyonoffmethod(128Hztuningforktwiceoneachfirsttoe,notingstartandstopofvibration)vibrationtestingbytimedmethod
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nerveconductionstudiesusedasreferencestandardspecificityof5of8testpointsinsensate,positivelikelihoodratio
vibrationtestingbyonoffmethod99%,likelihoodratio26.6vibrationtestingbytimedmethod98%,likelihoodratio18.5SWME96%,likelihoodratio10.2superficialpain97%,likelihoodratio9.2
combinationof2screeningtestsdidnotsignificantlyincreasediagnosticperformanceReferenceDiabetesCare2001Feb24(2):250 EBSCOhostFullTextfulltext
IpswichTouchTestappearstohavehighagreementwithmonofilamenttestforidentifyingriskoffootulcerinpatientswithdiabetes(level2[midlevel]evidence)
basedonindependentderivationandvalidationcohortstudieswithunclearblindinginderivationstudy,265adultswithdiabeteswereassessedwithIpswichTouchTestand10gaugemonofilamenttestIpswichTouchTestinvolveslightandbrief(12seconds)touchingof6sitesofthefeet(tipsofthefirst,third,andfifthtoesofbothfeet)withindexfinger55.5%classifiedasatriskoffootulcerbymonofilamenttest(2insensateareas)vibrationperceptionthresholdof25voltswasusedasadditionalreferencestandardperformanceofIpswichTouchTest(2insensateareas)foridentifyingriskoffootulcer
withmonofilamenttestasreferencestandardsensitivity91.8%specificity96.6%positivepredictivevalue97.1%negativepredictivevalue90.5%
withvibrationperceptionthresholdasreferencestandard,sensitivity75%andspecificity90%
invalidationstudy,331adultswithdiabeteswereassessedwithIpswichTouchTestathomeandinclinic25%ofpatientshad2insensateareasby10gaugemonofilamenttesting(referencestandard)performanceofIpswichTouchTest(2insensateareas)foridentifyingriskoffootulcer
athomesensitivity78.3%specificity93.9%positivepredictivevalue81.2%negativepredictivevalue92.8%
inclinic
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sensitivity81.2%specificity96.4%positivepredictivevalue89.9%negativepredictivevalue96.9%
ReferencesderivationstudyDiabetesCare2011Jul34(7):1517 EBSCOhostFullTextfulltextvalidationstudyDiabetMed2014Sep31(9):1100
neuropathicsensorysymptoms(numbnessofthefeet)arenotsensitivefordetectingpolyneuropathyinpatientswithtype2diabetes(level1[likelyreliable]evidence)
basedondiagnosticcohortstudy588patientswithtype2diabetesin26generalpracticesintheNetherlandshadblindedcomparisonofneuropathicsensorysymptomquestionnaireandneurologicexamscore>4on025scaleonneurologicexamimplieddiagnosisofdiabeticpolyneuropathy,32%patientshaddiabeticpolyneuropathyonexamneuropathicsymptomsassociatedwithdiabeticpolyneuropathywere
numbnessofthefeetsensoryalterationsymptomsofpain
forpatients68yearsold,numbnessoffeethad22%sensitivity,92%specificity,positivelikelihoodratio2.75,andnegativelikelihoodratio0.85ReferenceDiabetMed2000Feb17(2):105 EBSCOhostFullTextinACPJClub2000NovDec133(3):112
7itemMichiganNeuropathyScreeningInstrumentindexmaybespecificbutnotsensitivefordistalsymmetricalperipheralneuropathyinpatientswithtype1diabetes(level2[midlevel]evidence)
basedonderivationcohortstudywithoutvalidation1,184patients(meanage47years)withtype1diabeteswereanalyzedreferencestandardwasexaminationbyneurologistandabnormalnerveconductionfindingsin2anatomicallydistinctnervesamongsural,peroneal,andmediannerves30%ofpatientshaddistalsymmetricalperipheralneuropathyMichiganNeuropathyScreeningInstrument(MNSI)indexderivedfrom19itemMNSIandconsistsof4itemselfadministeredquestionnaireandclinicalexaminationscoredforabnormalfindings(totalscore07points)
questionnaire(yesresponsesscoredas1point)Areyourlegsand/orfeetnumb?Doyoueverhaveanypricklingfeelingsinyourlegsorfeet?Haveyoueverhadanopensoreonyourfoot?Hasyourdoctorevertoldyouthatyouhavediabeticneuropathy?
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PhysicianQualityReportingSystemQualityMeasures:
examination(yesresponsesscoredas1point)Isappearanceof1footabnormal?Areanklereflexesreducedorabsentin1foot?Isvibrationperceptionreducedorabsentin1foot?
diagnosticperformanceofMNSIindexusingcutpoint>2.77fordistalsymmetricalperipheralneuropathy
sensitivity43%specificity95%positivepredictivevalue80%negativepredictivevalue80%
ReferenceDiabetMed2012Jul29(7):937 EBSCOhostFullTextfulltextsomeolderindividualswithoutdiabetesmellitusshouldreceivethesamefootcarescreening,educationandfollowup
basedonstudyof183patientswithdiabetesand125patientswithoutdiabetesreferredtoaFootCareService38%ofpatientswithoutdiabetes>60yearsoldhadperipheralneuropathy(viaSemmesWeinsteinmonofilamenttest)orperipheralvasculardisease(anklebrachialindex
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Guidelines:
Internationalguidelines:
UnitedStatesguidelines:
theroutinescreeninginasymptomaticpatientscouldleadtooveruseofArterialBrachialIndex(ABI)andproceduresforperipheralarterialdiseasethatmaynotbebeneficial.Instead,thereshouldbeafocusonaddressingvascularriskinallpatientswithanemphasisonstatintreatment,bloodpressurecontrolandsmokingcessation."ReferenceACPPerformanceMeasureReview2015Apr27PDF
seePhysicianQualityReportingSystemQualityMeasuresforadditionalinformation
GuidelinesandResources
InternationalWorkingGrouponDiabeticFoot(IWGDF)2011guidelinesonmanagementandpreventionofdiabeticfootcanbefoundinDiabetesMetabResRev2012Feb28Suppl1:225 EBSCOhostFullTextfulltextwoundandwoundbedmanagementcanbefoundinDiabetesMetabResRev2012Feb28Suppl1:232 EBSCOhostFullTextfulltexttreatmentofdiabeticfootinfectionscanbefoundinDiabetesMetabResRev2012Feb28Suppl1:234 EBSCOhostFullTextfulltextdiagnosisandtreatmentofperipheralarterialdiseaseinpatientwithdiabetesandulcerationoffootcanbefoundinDiabetesMetabResRev2012Feb28Suppl1:236 EBSCOhostFullTextfulltext
internationalexpertevidencebasedrecommendationsonnegativepressurewoundtherapy:treatmentvariables(pressurelevels,woundfillerandcontactlayer)canbefoundinJPlastReconstrAesthetSurg2011Sep64Suppl:S1
AmericanCollegeofRadiology(ACR)AppropriatenessCriteriaforsuspectedosteomyelitisoffootinpatientswithdiabetesmellituscanbefoundatACR2012PDForatNationalGuidelineClearinghouse2012Oct22:37915InfectiousDiseasesSocietyofAmerica(IDSA)2012clinicalpracticeguidelineondiagnosisandtreatmentofdiabeticfootinfectionscanbefoundinClinInfectDis2012Jun54(12):e132 EBSCOhostFullTextPDForatNationalGuidelineClearinghouse2012Aug27:37220,executivesummarycanbefoundinClinInfectDis2012Jun54(12):1679 EBSCOhostFullTextPDFAmericanDiabetesAssociation(ADA)
AmericanDiabetesAssociation(ADA)positionstatementonstandardsofmedicalcareindiabetescanbefoundinDiabetesCare2015Jan38Suppl1:S1PDF
summaryofrevisions(DiabetesCare2015Jan38Suppl1:S4 EBSCOhostFullTextfulltext)1.strategiesforimprovingcare(DiabetesCare2015Jan38Suppl1:S5EBSCOhostFullTextfulltext)2.classificationanddiagnosisofdiabetes(DiabetesCare2015Jan38Suppl1:S8 EBSCOhostFullTextfulltext)3.initialevaluationanddiabetesmanagementplanning(DiabetesCare2015Jan38Suppl1:S17 EBSCOhostFullTextfulltext)
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4.foundationsofcare:education,nutrition,physicalactivity,smokingcessation,psychosocialcare,andimmunization(DiabetesCare2015Jan38Suppl1:S20EBSCOhostFullTextfulltext)5.preventionordelayoftype2diabetes(DiabetesCare2015Jan38Suppl1:S31 EBSCOhostFullTextfulltext)6.glycemictargets(DiabetesCare2015Jan38Suppl1:S33 EBSCOhostFullTextfulltext)7.approachestoglycemictreatment(DiabetesCare2015Jan38Suppl1:S41EBSCOhostFullTextfulltext)
8.cardiovasculardiseaseandriskmanagement(DiabetesCare2015Jan38Suppl1:S49 EBSCOhostFullTextfulltext)9.microvascularcomplicationsandfootcare(DiabetesCare2015Jan38Suppl1:S58 EBSCOhostFullTextfulltext)10.olderadults(DiabetesCare2015Jan38Suppl1:S67 EBSCOhostFullTextfulltext)11.childrenandadolescents(DiabetesCare2015Jan38Suppl1:S70EBSCOhostFullTextfulltext)12.managementofdiabetesinpregnancy(DiabetesCare2015Jan38Suppl1:S77 EBSCOhostFullTextfulltext)13.diabetescareinthehospital,nursinghome,andskillednursingfacility(DiabetesCare2015Jan38Suppl1:S80 EBSCOhostFullTextfulltext)14.diabetesadvocacy(DiabetesCare2015Jan38Suppl1:S86 EBSCOhostFullTextfulltext)
ADApolicystatementonpreventivefootcareindiabetescanbefoundinDiabetesCare2004Jan27Suppl1:S63 EBSCOhostFullTextfulltext
WisconsinDiabetesPreventionandControlProgram2012guidelineondiabetesmellitusessentialcareguidelinescanbefoundatWisconsinDepartmentofHealthServices2012MayPDFConvaTecSOLUTIONSwoundcarealgorithmcanbefoundatNationalGuidelineClearinghouse2014Jun30:47857Wound,Ostomy,andContinenceNursesSociety(WOCN)guidelineonmanagementofwoundsinpatientswithlowerextremityneuropathicdiseasecanbefoundatNationalGuidelineClearinghouse2012Nov12:38248,executivesummarycanbefoundinJWoundOstomyContinenceNurs2013JanFeb40(1):34WoundHealingSociety(WHS)guidelineontreatmentofdiabeticulcerscanbefoundinWoundRepairRegen2006NovDec14(6):680 EBSCOhostFullTextAmericanCollegeofFootandAnkleSurgeons(ACFAS)clinicalpracticeguidelineondiabeticfootdisorderscanbefoundinJFootAnkleSurg2006SepOct45(5Suppl):S1expertconsensusrecommendationsonadvancingstandardofcarefortreatingneuropathicfootulcersinpatientswithdiabetescanbefoundinOstomyWoundManage2010Apr56(4Suppl):S1NationalPressureUlcerAdvisoryPanel(NPUAP)guidelineonroleofnutritioninpressureulcerpreventionandtreatmentcanbefoundinAdvSkinWoundCare2009May22(5):212
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UnitedKingdomguidelines:
Canadianguidelines:
Europeanguidelines:
AustralianandNewZealandguidelines:
Reviewarticles:
AmericanSocietyofPlasticSurgeons(ASPS)guidelineonchronicwoundsoflowerextremitycanbefoundatASPSPDFConvaTecSOLUTIONSwoundcarealgorithmcanbefoundatNationalGuidelineClearinghouse2010Mar29:13559expertconsensusstatementonuseoftranscutaneousoximetryindiagnosisofperiwoundoxygentensionandassociationwithwoundhealingcanbefoundinUnderseaHyperbMed2009JanFeb36(1):43
NationalInstituteforHealthandClinicalExcellence(NICE)guidelineonpreventionandmanagementoffootproblemsintype2diabetescanbefoundatNICE2004Jan:CG10PDFNICEguidelineondiabeticfootproblemsinpatientmanagementcanbefoundatNICE2011Mar:CG119PDForatNationalGuidelineClearinghouse2012Apr23:34831,summarycanbefoundinBMJ2011Mar23342:d1280 EBSCOhostFullText
CanadianDiabetesAssociation(CDA)2008guidelineondiabetesmellituscanbefoundatCDA2008PDFRegisteredNursesAssociationofOntario(RNAO)guidelineonassessmentandmanagementoffootulcersforpeoplewithdiabetescanbefoundatRNAO2013MarPDForatNationalGuidelineClearinghouse2014May26:47566RNAOguidelineonreducingfootcomplicationsforpeoplewithdiabetescanbefoundatRNAO2004MarPDF
SpanishSocietyofFamilyandCommunityMedicine/SpanishSocietyofAngiologyandVascularSurgery(SociedadEspaoladeMedicinadeFamiliayComunitaria/SociedadEspaoladeAngiologayCirugaVascular[SEMFYC/SEACV])consensusdocumentoncriteriaforreferralbetweenlevelsofcareofpatientswithperipheralvasculardiseasecanbefoundinAtenPrimaria2012Sep44(9):556[Spanish]
AustralianDiabetesFootNetwork(ADFN)guidelineonmanagementofdiabetesrelatedfootulcerationcanbefoundinMedJAust2012Aug20197(4):226fulltextGeorgeInstituteforGlobalHealth/BakerIDIHeartandDiabetesInstitute/AdelaideHealthTechnologyAssessmentevidencebasedguidelineonprevention,identificationandmanagementoffootcomplicationsindiabetescanbefoundatNHMRC2011AprPDF
reviewsofdiabeticfootulcercanbefoundinBMJ2009Dec2339:b4905 EBSCOhostFullTextBMJ2006Feb18332(7538):407 EBSCOhostFullTextfulltextNEnglJMed2004Jul1351(1):48,commentarycanbefoundinNEnglJMed2004Oct14351(16):1694AmFamPhysician2002Nov166(9):1655 EBSCOhostFullTextfulltext,commentarycanbefoundinAmFamPhysician2003Dec1568(12):2327
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EBSCOhostFullTextfulltextLancet2003May3361(9368):1545 EBSCOhostFullText,commentarycanbefoundinLancet2003Nov29362(9398):1858 EBSCOhostFullTextJFamPract2005Sep54(9):768 EBSCOhostFullTextreviewoftreatmentcanbefoundinLancet2005Nov12366(9498):1725EBSCOhostFullTextreviewoffootulcersandamputationsindiabetescanbefoundinAmFamPhysician2009Oct1580(8):789fulltext
reviewofdiabeticfootcanbefoundinBMJ2003May3326(7396):977 EBSCOhostFullTextfulltextreviewofdiabeticfootinfectionscanbefoundinAmFamPhysician2013Aug188(3):177 EBSCOhostFullTextreviewofdiabeticfootinfectioncanbefoundinAmFamPhysician2008Jul178(1):71 EBSCOhostFullTextfulltextCanadianAgencyforDrugsandTechnologiesinHealth(CADTH)TechnologyOverviewonfootcareforpatientswithperipheralvasculardiseasecanbefoundatCADTH2010SepPDFeditorialreviewofchronicwoundcarecanbefoundinLancet2008Nov29372(9653):1860comprehensiveliteraturereviewofpreventionoffootulcersinpatientswithdiabetescanbefoundinJAMA2005Jan12293(2):217 EBSCOhostFullTextreviewseriescanbefoundinsupplementtoJFamPract2000Nov
reviewofscopeofproblemwithdiabeticfootcanbefoundinJFamPract2000Nov49(11Suppl):S3 EBSCOhostFullTextreviewoffootassessmentinpatientswithdiabetescanbefoundinJFamPract2000Nov49(11Suppl):S9 EBSCOhostFullText,commentarycanbefoundinJFamPract2001Apr50(4):373 EBSCOhostFullTextreviewofpreventionoffootproblemsinpatientswithdiabetescanbefoundinJFamPract2000Nov49(11Suppl):S30 EBSCOhostFullTextreviewofeffectivetreatmentstrategiescanbefoundinJFamPract2000Nov49(11Suppl):S40 EBSCOhostFullText
reviewoffootulcerscanbefoundinNEnglJMed2000Sep14343(11):787,commentarycanbefoundinNEnglJMed2001Jan11344(2):139AmericanDiabetesAssociationliteraturereviewonpreventivefootcarecanbefoundinDiabetesCare1998Dec21(12):2161reviewofapplicationofautologousderivedplateletrichplasmagelintreatmentofchronicwoundulcer:diabeticfootulcercanbefoundinJExtraCorporTechnol2010Mar42(1):20reviewofplateletrichplasmauseinwoundhealingcanbefoundinYaleJBiolMed2010Mar83(1):1fulltextreviewofuseofplateletgrowthfactorsintreatingwoundsandsofttissueinjuriescanbefoundinActaDermatovenerolAlpPanonicaAdriat2007Dec16(4):156PDFreviewofemergingevidenceforappropriateuseofwoundcaretechnologiesinlongtermcarecanbefoundinAnnalsofLongTermCare2007Nov15(11):35
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MEDLINEsearch:
ICD9codes:
ICD10codes:
Generalreferencesused:
reviewofprinciplesofcastingandsplintingcanbefoundinAmFamPhysician2009Jan179(1):16 EBSCOhostFullTextfulltext
tosearchMEDLINEfor(Diabeticfootulcer)withtargetedsearch(ClinicalQueries),clicktherapy,diagnosis,orprognosis
PatientInformation
handoutcanbefoundinAmFamPhysician1998Mar1557(6):1325fulltexthandoutcanbefoundinJAMA2005Jan12293(2):260fulltexthandoutfromPatientUKPDFhandoutfromMountSinaiHospitaltechnicalinformationondiabeticfootfromPatientPlusPDFhandoutondiabeticwoundcarefromAmericanPodiatricMedicalAssociationhandoutonprotectingyourfeetfromamputationanddiabetesfromMayoClinichandoutontotalcontactcastfromAmericanAcademyofFamilyPhysiciansorinSpanishhandoutonfootproblemswithdiabetesfromClevelandClinic
ICD9/ICD10Codes
686.8otherspecifiedlocalinfectionsofskinandsubcutaneoustissue686.9unspecifiedlocalinfectionsofskinandsubcutaneoustissue707.1ulceroflowerlimbs,exceptpressureulcer
707.10unspecifiedulceroflowerlimb707.11ulcerofthigh707.12ulcerofcalf707.13ulcerofankle707.14ulcerofheelandmidfoot707.15ulcerofotherpartoffoot707.19ulcerofotherpartoflowerlimb
707.8chroniculcerofotherspecifiedsites707.9chroniculcerofunspecifiedsite
E10.5insulindependentdiabetesmellituswithperipheralcirculatorycomplicationsE11.5noninsulindependentdiabetesmellituswithperipheralcirculatorycomplicationsE12.5malnutritionrelateddiabetesmellituswithperipheralcirculatorycomplicationsE13.5otherspecifieddiabetesmellituswithperipheralcirculatorycomplicationsE14.5unspecifieddiabetesmellituswithperipheralcirculatorycomplicationsL08.8otherspecifiedlocalinfectionsofskinandsubcutaneoustissueL97ulceroflowerlimb,notelsewhereclassifiedL98.4chroniculcerofskin,notelsewhereclassified
References
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Recommendationgradingsystemsused:
1.LipskyBA,BerendtAR,CorniaPB,etal.2012InfectiousDiseasesSocietyofAmericaclinicalpracticeguidelineforthediagnosisandtreatmentofdiabeticfootinfections.ClinInfectDis.2012Jun54(12):e13273 EBSCOhostFullTextPDF,executivesummarycanbefoundinClinInfectDis2012Jun54(12):1679EBSCOhostFullTextPDF2.SteedDL,AttingerC,ColaizziT,etal.Guidelinesforthetreatmentofdiabeticulcers.WoundRepairRegen.2006NovDec14(6):68092. EBSCOhostFullText
InfectiousDiseasesSocietyofAmerica(IDSA)gradesofrecommendationstrengthofrecommendation
Strongrecommendationdesirableeffectsclearlyoutweighundesirableeffects,orviceversaWeakrecommendationdesirableeffectscloselybalancedwithundesirableeffects,or(withLoworVerylowqualityevidence)uncertaintyinestimatesofdesirableeffects,harms,andburdensotheymaybecloselybalanced
qualityofevidenceHighqualityevidenceconsistentevidencefromwellperformedrandomizedcontrolledtrials(RCTs)orexceptionallystrongevidencefromunbiasedobservationalstudiesModeratequalityevidenceevidencefromRCTswithimportantlimitations(inconsistentresults,methodologicflaws,indirect,orimprecise)orexceptionallystrongevidencefromunbiasedobservationalstudiesLowqualityevidenceevidencefor1criticaloutcomefromobservationalstudies,RCTswithseriousflaws,orindirectevidenceVerylowqualityevidenceevidencefor1criticaloutcomefromunsystematicclinicalobservationsorveryindirectevidence
ReferenceIDSA2012clinicalpracticeguidelineondiagnosisandtreatmentofdiabeticfootinfections(ClinInfectDis2012Jun54(12):e132 EBSCOhostFullText)PDF
AmericanDiabetesAssociation(ADA)evidencegradingsystemforclinicalpracticerecommendations
GradeAclearevidencefromwellconducted,generalizable,randomizedcontrolledtrials(RCTs)thatareadequatelypowered,includingevidencefromwellconductedmulticentertrialormetaanalysisthatincorporatedqualityratingsinanalysiscompellingnonexperimentalevidence,specifically,"allornone"ruledevelopedbyCenterforEvidenceBasedMedicineatOxfordsupportiveevidencefromwellconductedRCTsthatareadequatelypowered,includingevidencefromwellconductedtrialat1institutionormetaanalysisthatincorporatedqualityratingsinanalysis
GradeBsupportiveevidencefromwellconductedcohortstudies,includingevidencefromwellconductedprospectivecohortstudyorregistryormetaanalysisofcohort
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studiessupportiveevidencefromawellconductedcasecontrolstudy
GradeCsupportiveevidencefrompoorlycontrolledoruncontrolledstudies
evidencefromrandomizedclinicaltrialswith1majoror3minormethodologicflawsthatcouldinvalidateresultsevidencefromobservationalstudieswithhighpotentialforbias(suchascaseserieswithcomparisontohistoricalcontrols)evidencefromcaseseriesorcasereports
conflictingevidencewithweightofevidencesupportingrecommendationGradeEexpertconsensusorclinicalexperienceReferenceADA2015positionstatementonstandardsofmedicalcareindiabetes:introduction(DiabetesCare2015Jan38Suppl1:S1 EBSCOhostFullTextfulltext)
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