the diabetic foot - nhm · the diabetic foot – quick reference guide ver. 3.0 (draft) 1....
TRANSCRIPT
TheDiabeticFoot–QuickReferenceGuideVer.3.0(Draft)
STANDARD TREATMENT GUIDELINES
The Diabetic foot
Prevention and management in India
Quick Reference Guide (Draft) January 2016
Ministry of Health & Family Welfare Government of India
TheDiabeticFoot–QuickReferenceGuideVer.3.0(Draft)
TABLEOFCONTENTS-1. INTRODUCTION–...................................................................................................................3
2. CASEDEFINITION–.................................................................................................................3
3. INCIDENCEOFDIABETICFOOTININDIA.................................................................................3
4. RECOMMENDATIONS.............................................................................................................4ClinicalPathway1-OverviewofFootcareinDiabetes..................................................................4ClinicalPathway2-PreventionofDiabeticFoot...........................................................................5
4.1:PREVENTION...............................................................................................................................64.2ASSESSMENT,CLASSIFICATIONANDREFERRAL.......................................................................................8
ClinicalPathway2.1–AssessmentofPatients............................................................................11ClinicalPathway3-OverviewofManagementofDiabeticFoot................................................12
4.3:DIABETICFOOTINFECTIONS......................................................................................................134.4:WOUNDCARE...........................................................................................................................15
ClinicalPathway3.1-CareofAcuteWound...............................................................................16ClinicalPathway3.2-CareofChronicWound............................................................................17
4.5:FOOTWEAR...............................................................................................................................184.6TREATMENTOFDIABETICFOOTWITHOSTEOMYELITIS........................................................................194.7.CHARCOT’SFOOT..........................................................................................................................20
ClinicalPathway3.3-ManagementofCharcot’sFoot................................................................214.8:SURGICALINTERVENTIONSANDREVASCULARIZATION............................................................22
TheDiabeticFoot–QuickReferenceGuideVer.3.0(Draft)
1. Introduction–India is set to become the diabetes capital of the world with a projected 109 million individuals with diabetes by 2035.3 India ranks second (after China) with more than 66.8 million diabetics in the age group of 20-70. The prevalence of Diabetes in India is 8.6% 4 and, as of 2013, more than 1 million Indians die each year due to diabetes related causes.5 Diabetic foot care is one of the most ignored aspects of diabetes care in India. 24 Due to social, religious, and economic compulsions, many people walk barefoot. Poverty and lack of education lead to usage of inappropriate footwear and late presentation of foot lesions. Many non-medically qualified persons are interfering in the treatment of diseases, including diabetes. Patients also try home remedies before visiting their physicians. 24 It estimated that 90% of diabetic patients in India do not see a specialist in their lifetime.25 Problem is further worsened by a delay in accessing healthcare due to patient approaching informal care providers and alternative medicine prescribers. There is a lack of a good evidence-based standard guideline on Diabetic foot are in India. Currently, diabetic feet are treated by individual practitioners. Physicians, General surgeons, orthopaedic surgeons, primary care physicians, endocrinologists and podiatrists all look after the diabetic feet. But neither their roles, responsibilities nor the protocols are clearly defined in the public domain. Moreover, in the Indian context, due to the pronounced variability in the health care system, a common national guidance for providing curative as well as preventive methods to curb the growth of diabetic foot in the future is essential. Hence, it is a public health imperative to create an integrated framework for comprehensive management of diabetic foot.
2. CaseDefinition–Diabetic foot as defined by the World Health Organization is, “The foot of a diabetic patient that has the potential risk of pathologic consequences, including infection, ulceration, and/or destruction of deep tissues associated with neurologic abnormalities, various degrees of peripheral vascular disease, and/or metabolic complications of diabetes in the lower limb”.
3. IncidenceofDiabeticfootinIndiaDiabetic Foot (DF) is one of the most common complications for admissions imposing tremendous medical and financial burden 6 on our healthcare system. 7 The lifetime risk of a person with diabetes having a foot ulcer could be as high as 25%8 and is the commonest reason for hospitalization of diabetic patients (about 30%) and absorbs about 20% of the total health-care costs, more than all other diabetic complications.9, 10 The prevalence of foot ulcers in diabetics attending a centre managing diabetic foot (both indoor and outdoor setup) in India is 3%.11, 12 Foot ulcers among outpatient and inpatient diabetics attending hospitals in rural India was found to be 10.4%.13
Peripheral vascular disease (PVD) occurs in about 3.2% diabetics below 50 years of age and rises to 55% in those above 80 years of age. 14 15% of those with diabetes for a decade suffer from diabetic foot, where as it increases to almost 50% by another decade.15 Approximately, 85% of non-traumatic lower limb amputations are seen in patients with prior history of diabetic foot ulcer.16,17 Each year, more than 1 million people with diabetes lose at least a part of their leg due to diabetic foot. It shows that every 20 seconds a limb is lost in the world somewhere. 18 In India, though recent population based data is not available, it is estimated that approximately 45,000 legs are amputated every year in India. The vast majority (75%) of these are probably preventable because the amputation often results from an infected neuropathic foot.19 More than half of all foot ulcers become infected, requiring hospitalization, while 20% of
TheDiabeticFoot–QuickReferenceGuideVer.3.0(Draft)
infections result in amputation.20 After a major amputation, 50% of people will have the other limb amputated within two years’ time. People with a history of diabetic foot ulcer have a 40% greater 10-year death rate than people with diabetes alone
4. Recommendations ClinicalPathway1-OverviewofFootcareinDiabetes
FOOTCAREinDiabetes(Pathwayno.1)
REDUCEtheriskofDiabeticFootproblem
(Gotopathwayno.2)
MANAGEtheDiabeticFootproblem
(Gotopathwayno.3)
TheDiabeticFoot–QuickReferenceGuideVer.3.0(Draft)
ClinicalPathway2-PreventionofDiabeticFoot
REDUCEtheriskofDiabeticFootproblem
(Pathwayno.2)
EducatethepatientregardingDFcare(GotothePatientInformationDocument)
Frequencyoffollowup(GototheRecommendationno.4.1.1)
AssessingtheRisk(GototheRecommendationno.4.2.1)
ManagingtheRisk(GototheRecommendationnos.
4.1.2to4.1.10andalso4.5.1to4.5.8)
MANAGEtheDiabeticFootproblem
(Gotopathwayno.3)
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4.1:PREVENTIONOverview:1.Identificationoftheat-riskfoot2.Regularinspectionandexaminationoftheat-riskfoot3.Educationofpatient,familyandhealthcareproviders4.Routinewearingofappropriatefootwear5.Treatmentofpre-ulcerativesigns4.1.1PreventionofDiabeticfootproblems4.1.1Toidentifyapersonwithdiabetesatriskforfootulceration,examinethefeetannually/sixmonthly/quarterly/monthly(dependingonpatient’sriskcategory)toseekevidenceforsignsorsymptomsofperipheralneuropathyandperipheralarterydisease.RiskClassificationSystemandpreventivescreeningfrequency
Category Characteristic Frequency
0 Noperipheralneuropathy Onceayear
1 Peripheralneuropathy Onceeverysixmonths
2 Peripheralneuropathywithperipheralarterydiseaseand/orafootdeformity
Onceevery3-6months
3 Peripheralneuropathyandahistoryoffootulcerorlower-extremityamputation
Onceevery1-3months
source:TheIWGDFguidelines20154.1.2Inapersonwithdiabeteswhohasperipheralneuropathy,screenfor:ahistoryoffootulcerationorlower-extremityamputation;peripheralarterydisease;footdeformity;pre-ulcerativesignsonthefoot;poorfoothygiene;andill-fittingorinadequatefootwear.4.1.3Treatanypre-ulcerativesignonthefootofapatientwithdiabetes.Thisincludes:removingcallus;protectingblistersanddrainingwhennecessary;treatingingrownorthickenedtoenails;treatinghaemorrhagewhennecessary;andprescribingantifungaltreatmentforfungalinfections.4.1.4Toprotecttheirfeet,instructanat-riskpatientwithdiabetesnottowalkbarefoot,insocks,orinthin-soledstandardslippers,whetherathomeorwhenoutside.4.1.5Instructanat-riskpatientwithdiabetesto:dailyinspecttheirfeetandtheinsideoftheirshoes;dailywashtheirfeet(withcarefuldryingparticularlybetweenthetoes);avoidusingchemicalagentsorplasterstoremovecallusorcorns;useemollientstolubricatedryskin;andcuttoenailsstraightacross.4.1.6Instructanat-riskpatientwithdiabetestowearproperlyfittingfootweartopreventafirstfootulcer,eitherplantarornon-plantar,orarecurrentnon-plantarfootulcer.Whenafootdeformityorapre-ulcerativesignispresent,considerprescribingtherapeuticshoes,custom-madeinsoles,ortoeorthosis.4.1.7Instructahigh-riskpatientwithdiabetestomonitorfootskintemperatureathometopreventafirstorrecurrentplantarfootulcer.Thisaimsatidentifyingtheearlysignsof
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inflammation,followedbyactiontakenbythepatientandcareprovidertoresolvethecauseofinflammation.4.1.8Topreventafirstfootulcerinanat-riskpatientwithdiabetes,provideeducationaimedatimprovingfootcareknowledgeandbehaviour,aswellasencouragingthepatienttoadheretothisfootcareadvice.4.1.9Topreventarecurrentplantarfootulcerinanat-riskpatientwithdiabetes,prescribetherapeuticfootwearthathasademonstratedplantarpressurerelievingeffectduringwalkingandencouragethepatienttowearthisfootwear.4.1.10Topreventarecurrentfootulcerinanat-riskpatientwithdiabetes,provideintegratedfootcare,whichincludesprofessionalfoottreatment,adequatefootwearandeducation.Thisshouldberepeatedorre-evaluatedonceeveryonetothreemonthsasnecessary.
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4.2Assessment,ClassificationandReferral4.2.1Assessingtheriskofdevelopingadiabeticfootproblem4.2.1aEvaluateadiabeticpatientpresentingwithafootwoundat3levels:thepatientasawhole,theaffectedfootorlimb,andtheinfectedwound.4.2.1bAssesstheaffectedlimbandfootforarterialischemia,venousinsufficiency,presenceofprotectivesensation,andbiomechanicalproblems.Explanatorynote:Biomechanicalproblemsmeansanatomicalandphysiologicaldisturbancesofthefoot,i.e.,structuralchangeswhichhappeninthebones,jointsandmusclesofthefootofdiabeticsandthechangesinthebloodcirculationandnervesensationofthefootofdiabetics.4.2.2.ClassificationofDiabeticfoot4.2.2aAssesstheseverityofanydiabeticfootinfectionusingtheInfectiousDiseasesSocietyofAmerica/InternationalWorkingGroupontheDiabeticFootClassificationsystem.Table 1. Infectious Diseases Society of America and International Working Group on the Diabetic Foot Classifications of Diabetic Foot Infection
Clinical Manifestation of Infection PEDIS Grade
IDSA Infection
Uninfected: No symptoms or signs of infection
1 Uninfected
Infected: At least two of the following items are present: • Local swelling or induration • Erythema >0.5cm around the wound • Local tenderness or pain • Local warmth • Purulent discharge (thick, opaque to white or sanguineous secretion) Exclude other causes of an inflammatory response of the skin (eg, trauma, gout, acute Charcot neuro-osteoarthropathy, fracture, thrombosis, venous stasis). Local infection involving only the skin and the subcutaneous tissue (without involvement of deeper tissues and without systemic signs as described below). An erythema, must be </=2 cm around the ulcer.
2 Mild
Local infection (as described above) with erythema > 2 cm, or involving structures deeper than skin and subcutaneous tissues (eg, abscess, osteomyelitis, septic arthritis, fasciitis), and No systemic inflammatory response signs (as described below)
3 Moderate
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Local infection (as described above) with the signs of SIRS, as manifested by ≥2 of the following: • Temperature >38°C or <36°C • Heart rate >90 beats/min • Respiratory rate >20 breaths/min or PaCO2 <32 mm Hg • White blood cell count >12,000 or <4000 cells/µL or ≥10% immature (band) forms
3 Severea
Abbreviations: IDSA, Infectious Diseases Society of America; PaCO2, partial pressure of arterial carbon dioxide; PEDIS, perfusion, extent/size, depth/tissue loss, infection, and sensation; SIRS, systemic inflammatory response syndrome. 4.2.2bDonotusetheWagnerclassificationsystemtoassesstheseverityofadiabeticfootulcer.4.2.3ReferralforDiabeticfootproblems4.2.3aInitiallyhospitalizeallpatientswithasevereinfection,selectedpatientswithamoderateinfectionwithcomplicatingfeatures(eg,severeperipheralarterialdisease[PAD]orlackofhomesupport),andanypatientunabletocomplywiththerequiredoutpatienttreatmentregimenforpsychologicalorsocialreasons.Alsohospitalizepatientswhodonotmeetanyofthesecriteria,butarefailingtoimprovewithoutpatienttherapy.(Also refer to Table-3 and 4 below, for explanatory notes.) Table 3: Characteristics suggesting a more serious diabetic foot infection
source : from The IWGDF guidelines 2015 Table 4: Factors indicating that hospitalization may be necessary
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source : from The IWGDF guidelines 2015 4.2.3bPriortobeingdischarged,makesurethatapatientwithaDFI(DiabeticFootInfection)isclinicallystable;hashadanyurgentlyneededsurgeryperformed;hasachievedacceptableglycemiccontrol;isabletomanage(onhis/herownorwithhelp)atthedesignateddischargelocation;andhasawelldefinedplanthatincludesanappropriateantibioticregimentowhichhe/shewilladhere,anoff-loadingscheme(ifneeded),specificwoundcareinstructions,andappropriateoutpatientfollow-up.
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ClinicalPathway2.1–AssessmentofPatients
ClinicalAssessmentatthreelevels
Patientasawhole Affectedlimb Wound/Ulcer
DurationofDM Nowound Charcot’sFootGlycaemicControl(HbA1c)Anti-DMmedicationsOtherco-morbidities Refertohighercentre(HTN,IHD,CKD,etc)ControlofHTNManagementofIHD(Aspirin/Clopidogrel/Statin)Smokingcessation NoCellulitis CellulitispresentPasthistoryofUlceration/Infection/Amputation/Charcot’sfoot Lookfor OralAntibiotics Mild BedRest ScalinginOPD Corns/Calluses Followup
Footwearmodification
TopicalAntifungal Webspace Moderate Referto fungalinfection higher Adequate Severe centre
trimming In-growingtoe-nails
ProtectiveFootwear GrossDeformitiesCorrectiveSurgery
Skinchanges
SuspectPAD Absentsweating AbsentpedalpulsesReferto ABI<0.9highercentre 10-gmMonofilamenttest
SuspectNeuropathy Ipswichtouchtest
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ClinicalPathway3-OverviewofManagementofDiabeticFoot
MANAGEMENToftheDiabeticFootproblem
(Pathwayno.3)
WhentoRefer?(GototheRecommendationnos.4.2.3
and4.7.2)
Informthepatienthis/herclinicalconditionandwhatallinvestigationsand
treatmentareneeded
Charcot’sFoot(4.7.1)
DFinfection/Ulcer/Osteomyelitis
(4.2.2,4.3.1,4.3.2)
Vasculopathy(4.8.14)
Investigations(4.7.3to4.7.5)
Investigations(4.3.3,4.3.4,4.6.1to4.6.4)
Investigations(4.8.9to4.8.13,4.8.15,4.8.16)
Treatment(4.7.6to4.7.10)
Treatment(4.3.5,
4.4.1to4.4.11,4.5.1to4.5.8,4.6.5to4.6.7,4.8.1to4.8.8
4.8.12to4.8.13,4.8.21to4.8.24)
Treatment(4.8.12,4.8.13,4.8.17to4.8.24)
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4.3:DIABETICFOOTINFECTIONS4.3.1Considerthepossibilityofinfectionoccurringinanyfootwoundinapatientwithdiabetes.Evidenceofinfectiongenerallyincludesclassicsignsofinflammation(redness,warmth,swelling,tenderness,orpain)orpurulentsecretions,butmayalsoincludeadditionalorsecondarysigns(e.g.,nonpurulentsecretions,friableordiscoloredgranulationtissue,underminingofwoundedges,foulodor).4.3.2Beawareoffactorsthatincreasetheriskfordiabeticfootinfections(DFI)andespeciallyconsiderinfectionwhenthesefactorsarepresent;theseincludeawoundforwhichtheprobe-to-bone(PTB)testispositive;anulcerationpresentfor>30days;ahistoryofrecurrentfootulcers;atraumaticfootwound;thepresenceofperipheralvasculardiseaseintheaffectedlimb;apreviouslowerextremityamputation;lossofprotectivesensation;thepresenceofrenalinsufficiency;orahistoryofwalkingbarefoot.4.3.3TakeplainradiographsoftheaffectedfootofallpatientpresentingwithanewDiabeticFootInfectiontolookforbonyabnormalities(deformity,destruction)aswellasforsofttissuegasandradio-opaqueforeignbodies.4.3.4WhenandhowtoobtainculturefromDiabeticfootpatients?4.3.4aForclinicallyuninfectedwounds,donotcollectaspecimenforculture.4.3.4bSendaspecimenforculturethatisfromdeeptissue,obtainedbybiopsyorcurettageandafterthewoundhasbeencleansedanddebrided.Avoidswabspecimens,especiallyofinadequatelydebridedwounds,astheyprovidelessaccurateresults.Explanatorynote:Washthewoundwithsalineandthesurroundingskinwithantisepticsolutionbeforetakingculturetoavoidcontaminationofthespecimenobtainedforculture.4.3.4cDonotobtainrepeatculturesunlessthepatientisnotclinicallyrespondingtotreatment.Explanatorynote-Expertconsensussaysthatifthesignsofinflammationdonotsubsideevenafter72hoursofstartingtreatment,thenitshouldbeconsideredthatpatientisnotresponding.4.3.4dForinfectedwounds,cliniciansshouldsendappropriatelyobtainedspecimensforculturepriortostartingempiricantibiotictherapy,ifpossible.Culturesmaybeunnecessaryforamildinfectioninapatientwhohasnotrecentlyreceivedantibiotictherapy.4.3.5.SelectionofAntibioticandwhenshoulditbemodified?4.3.5aDonottreatclinicallyuninfectedwoundswithantibiotictherapy.4.3.5bPrescribeantibiotictherapyforallinfectedwoundsbutcautionthatthisisofteninsufficientunlesscombinedwithappropriatewoundcare.4.3.5cBasetherouteoftherapylargelyoninfectionseverity.Preferparenteraltherapyforallsevere,andsomemoderate,DFls,atleastinitiallywithaswitchtooralagentswhenthepatientissystemicallywellandcultureresultsareavailable.Clinicianscanprobablyusehighlybioavailableoralantibioticsaloneinmostmild,andinmanymoderate,infectionsandtopicaltherapyforselectedmildsuperficialinfections.
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4.3.5dSelectanempiricantibioticregimenonthebasisoftheseverityoftheinfectionandthelikelyetiologicagent(s).a.Formildtomoderateinfectionsinpatientswhohavenotrecentlyreceivedantibiotictreatment,therapyjusttargetingaerobicgram-positivecocci(GPC)issufficientb.Formostsevereinfections,startbroad-spectrumempiricantibiotictherapy,pendingcultureresultsandantibioticsusceptibilitydata.c.EmpirictherapydirectedatP.aeruginosaisusuallyunnecessaryexceptforpatientswithriskfactors*fortrueinfectionwiththisorganism.d.ConsiderprovidingempirictherapydirectedagainstMRSAinapatientwithapriorhistoryofMRSAinfection;whenthelocalprevalence**ofMRSAcolonizationorinfectionishigh;oriftheinfectionisclinicallysevere.Explanatorynotes:*RiskfactorsfortrueinfectionwithPseudomonasaeruginosaincludeImmunocompromisedstatus,ChronicKidneyDisease,warmclimateandfrequentexposureoffoottowater.**ThelocalprevalenceofMRSA(i.e.,percentageofallS.aureusclinicalisolatesinthatlocalethataremethicillinresistant)ishighenough(perhaps50%foramildand30%foramoderatesofttissueinfection)thatthereisareasonableprobabilityofMRSAinfection.4.3.5eGiveaninitialantibioticcourseforasofttissueinfectionofabout1–2weeksformildinfectionsand2–3weeksformoderatetosevereinfections.4.3.5fContinueantibiotictherapyuntil,butnotbeyond,resolutionoffindingsofinfection,butnotthroughcompletehealingofthewound.4.3.5gAdministerparenteraltherapyinitiallyformostsevereinfectionsandsomemoderateinfections,withaswitchtooraltherapywhentheinfectionisresponding.
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4.4:WOUNDCARE4.4.1Cleanulcersregularlywithcleanwaterorsaline*,debridethemwhenpossibleinordertoremovedebrisfromthewoundsurfaceanddressthemwithasterile,inertdressinginordertocontrolexcessiveexudateandmaintainawarm,moistenvironmentinordertopromotehealing**.Explanatorynote:*Cleanwaterisboiledcooledwater(distilledwater)**DonotuseH2O2,EUSOL,etc4.4.2Selectdressingsprincipallyonthebasisofexudatecontrol,comfortandcost.4.4.3Donotuseantimicrobialdressingswiththegoalofimprovingwoundhealingorpreventingsecondaryinfection.4.4.4Donotofferthefollowingtotreatdiabeticfootulcers,unlessaspartofaclinicaltrial:·Electricalstimulationtherapy,autologousplatelet-richplasmagel,regenerativewoundmatricesanddalteparin.·Growthfactors(granulocytecolony-stimulatingfactor[G-CSF],platelet-derivedgrowthfactor[PDGF],epidermalgrowthfactor[EGF]andtransforminggrowthfactorbeta[TGF-β]).·Hyperbaricoxygentherapy.4.4.5Considerdermalorskinsubstitutesasanadjuncttostandardcarewhentreatingdiabeticfootulcers,onlywhenhealinghasnotprogressedandontheadviceofthemultidisciplinaryfootcareservice.4.4.6Considernegativepressurewoundtherapyaftersurgicaldebridementfordiabeticfootulcers,ontheadviceofthemultidisciplinaryfootcareservice.4.4.7Donotselectagentsreportedtoimprovewoundhealingbyalteringthebiologyofthewound,includinggrowthfactors,bioengineeredskinproductsandgases,inpreferencetoacceptedstandardsofgoodqualitycare.4.4.8Donotselectagentsreportedtohaveanimpactonwoundhealingthroughalterationofthephysicalenvironment,includingthroughtheuseofelectricity,magnetism,ultrasoundandshockwaves,inpreferencetoacceptedstandardsofgoodqualitycare.4.4.9Donotselectsystemictreatmentsreportedtoimprovewoundhealing,includingdrugsandherbaltherapies,inpreferencetoacceptedstandardsofgoodqualitycare.4.4.10Redistributionofpressureoffthewoundtotheentireweight-bearingsurfaceofthefoot(“off-loading”).Whileparticularlyimportantforplantarwounds,thisisalsonecessarytorelievepressurecausedbydressings,footwear,orambulationtoanysurfaceofthewound.4.4.11Whendecidingaboutwounddressingsandoffloadingwhentreatingdiabeticfootulcers,takeintoaccounttheclinicalassessmentofthewoundandtheperson’spreference,andusedevicesanddressingswiththelowestacquisitioncostappropriatetotheclinicalcircumstances.
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ClinicalPathway3.1-CareofAcuteWound
Wound/Ulcer
Acute Chronic
NotInfected Infected SeparateFlowchartSimpledressingsonly Off-loadingNoantibiotics RuleoutOsteomyelitis(PTBtest,X-ray)
TakeadequatespecimenforcultureAssesspatient’sclinicalcondition
Patientstable Patientunstable WetGangreneNoSepsis Sepsispresent
OralAntibiotics Hospitalization AMPUTATIONWoundCare/Dressings i.v.antibiotics Glycaemiccontrol DebridementFollow-up Woundcare/Dressings
Improvement NoImprovementContinuesame Nothreattolife ThreattolifepresentProtectiveFootwearafterulcerhealsPeriodicEvaluation EvaluatefurtherforOsteomyelitis,topreventrecurrence PAD,Neuropathy,Charcot’sfoot
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ClinicalPathway3.2-CareofChronicWound
ChronicWound/Ulcer(non-healingfor>6weeks)
AssessVascularity CheckforLOPS AssessforOsteomyelitis GrossDeformities (LossofProtectiveSensation) Inabilitytofeelthe TherapeuticFootwearPalpatepedalpulses 10-gmmonofilament CalculateABI NoreliefArterialColourDoppler Neuropathypresent Correctivesurgery Off-loading
PADpresent ProtectiveFootwear Patientmoribund PatientFitforSurgery PTBtest Inconclusive Microangiopathy Largevesseldisease X-ray HighSuspicion MRAngio/CTAngio DSA ConfirmedOsteomyelitis MRIMedical Planformanagement Revasularisation Hospitalization i.v.antibioticsfor4-6weeks Debridement&Dressings Off-loading
ProtectiveFootwearaftercure
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4.5:FOOTWEAR4.5.1Tohealaneuropathicplantarforefootulcerwithoutischemiaoruncontrolledinfectioninapatientwithdiabetes,offloadwithanon-removableknee-highdevicewithanappropriatefoot-deviceinterface.Non-removable(cast)walker:Sameasremovable(cast)boot/walkerbutthenwithalayer(s)offibreglasscastmaterialcircumferentiallywrappedarounditrenderingitirremovable(alsoknownas"instanttotalcontactcast")4.5.2Whenanon-removableknee-highdeviceiscontraindicatedornottoleratedbythepatient,consideroffloadingwitharemovableknee-highwalkerwithanappropriatefoot-deviceinterfacetohealaneuropathicplantarforefootulcerinapatientwithdiabetes,butonlywhenthepatientcanbeexpectedtobeadherenttowearingthedevice.Removable(cast)boot/walker:Prefabricatedremovableknee-highbootwitharockerorrolleroutsoleconfiguration,paddedinterior,andaninsertableandadjustableinsolewhichmaybetotalcontact.4.5.3Whenaknee-highdeviceiscontraindicatedorcannotbetoleratedbythepatient,consideroffloadingwithaforefootoffloadingshoe,castshoe,orcustom-madetemporaryshoetohealaneuropathicplantarforefootulcerinapatientwithdiabetes,butonlyandwhenthepatientcanbeexpectedtobeadherenttowearingtheshoes.4.5.4Instructanat-riskpatientwithdiabetestowearproperlyfittingfootweartopreventafirstfootulcer,eitherplantarornon-plantar,orarecurrentnon-plantarulcer.Whenafootdeformityorapre-ulcerativesignispresent,considerprescribingtherapeuticshoes,custom-madeinsoles,ortoeorthosis*.*Toeorthosis:-Anin-shoeorthosistoachievesomealterationinthefunctionofthetoe.4.5.5Topreventarecurrentplantarfootulcerinanat-riskpatientwithdiabetes,prescribetherapeuticfootwearthathasademonstratedplantarpressurerelievingeffectduringwalkingandencouragethepatienttowearthisfootwear.4.5.6Instructapatientwithdiabetesnottouseconventionalorstandardtherapeuticfootweartohealaplantarfootulcer.Explanatorynote:Usefootwearwithfollowingfeatures-Sandals:shouldhaveadjustablestraps,insole,fullheelcounterandrigidoutsole.Shoes:shouldhavewidetoeboxextradepthandwithoutlaces.4.5.7Considerusingshoemodifications,temporaryfootwear,toespacersororthosestooffloadandhealanon-plantarfootulcerwithoutischemiaoruncontrolledinfectioninapatientwithdiabetes.Thespecificmodalitywilldependonthetypeandlocationofthefootulcer.4.5.8Ifotherformsofbiomechanicalreliefarenotavailable,considerusingfeltedfoam*incombinationwithappropriatefootweartooffloadandhealaneuropathicfootulcerwithoutischemiaoruncontrolledinfectioninapatientwithdiabetes.
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Feltedfoam-Afibrous,unwovenmaterialbackedbyfoamwithabsorbingandcushioningcharacteristics.Thefoamisgenerally‘rubberfoam’or‘PUfoam’whichisformedbyeitherapolyesterorpolyetherpolyolresin,inconjunctionwithwaterandToluenediIsocyanate,alongwithvariouscatalystsandblowingagentsandcolouringpigmentstogivethedesiredcompression.
4.6TreatmentofDiabeticfootwithosteomyelitis4.6.1Foraninfectedopenwound,performaprobe-to-bonetest;inapatientatlowriskforosteomyelitisanegativetestlargelyrulesoutthediagnosis,whileinahighriskpatientapositivetestislargelydiagnostic.4.6.2MarkedlyelevatedESRissuggestiveofosteomyelitisinsuspectedcases.Explanatorynote:Testsforseruminflammatorymarkersarecostlyandnotwidelyavailable,exceptESR.AlsothesetestsarenotdiagnosticofDFO.4.6.3IfosteomyelitisissuspectedinapersonwithdiabetesbutisnotconfirmedbyinitialX-ray,consideranMRItoconfirmthediagnosis.InplaceswhereMRIisunavailable,diagnoseosteomyelitisbythePTBtest(clinically)and/ortakingaBonebiopsyandculture.Explanatorynote:“ExpertConsensussaysthatasavailabilityofMRIislimitedacrossthecountry,itisrecommendedtouseMRIwhereveravailable.”Attheprimaryandsecondaryhealthcentrelevels,thePTBtestandbonebiopsyandculturearemorefeasibleandeconomicalandreasonablyaccurate.4.6.4Adefinitediagnosisofboneinfectionusuallyrequirespositiveresultsonbothhistologicalandmicrobiologicalexaminationsofanasepticallyobtainedbonesample,butthisisusuallyrequiredonlywhenthediagnosisisindoubtordeterminingthecausativepathogen’santibioticsusceptibilityiscrucial.4.6.5Avoidusingresultsofsofttissueorsinustractspecimensforselectingantibiotictherapyforosteomyelitisastheydonotaccuratelyreflectbonecultureresults.4.6.6Whenaradicalresectionleavesnoremaininginfectedtissue*,wesuggestprescribingantibiotictherapyforonlyashortduration(2–5days).Whenthereispersistentinfectedornecroticbone,wesuggestprolonged(≥4weeks)antibiotictreatment.Explanatorynote:*Aproximalbonehistopathtobedoneifavailabletogetaclearmarginandconfirmthatnoinfectedboneremains.4.6.7ForspecificallytreatingDiabeticfootosteomyelitis,wedonotcurrentlysupportusingadjunctivetreatmentssuchashyperbaricoxygentherapy,growthfactors(includinggranulocytecolonystimulatingfactor),maggots(larvae),ortopicalnegativepressuretherapy(eg,vacuum-assistedclosure).
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4.7.Charcot’sFoot4.7.1SuspectacuteCharcotarthropathyifthereisredness,warmth,swellingordeformity(inparticular,whentheskinisintact),especiallyinthepresenceofperipheralneuropathyorrenalfailure.ThinkaboutacuteCharcotarthropathyevenwhendeformityisnotpresentorpainisnotreported.4.7.2Referthepersonwithsuspectedcharcot’sfootearly(withinoneweek)tothe“DiabeticFootCareCenter”toconfirmthediagnosis,andoffernon-weight-bearingtreatmentuntildefinitivetreatmentcanbestarted.DiabeticFootcarecentre:-InIndia,sincetherearenominimumstandardsofservicesofferedtothediabeticfootpatients,inourrecommendationswehaveusedthistermtodenotethisfacility,whichmayexistattheGeneralPractitioner’soffice,Primaryhealthcentre,Secondarycarecentreoratatertiarycarecentre.Preferably,thediabeticfootcarecentreshouldconsistofatleastasurgeon,aphysician,andanorthotist.4.7.3IfacuteCharcotarthropathyissuspected,X-raytheaffectedfoot.ConsideranMRIiftheX-rayisnormalbutclinicalsuspicionstillremains.4.7.4Distinguishingthebonychangesofosteomyelitisfromthoseofthelesscommonentityofdiabeticneuro-osteoarthropathy(Charcotfoot)maybeparticularlychallengingandrequiresconsideringclinicalinformationinconjunctionwithimaging.4.7.5Clinicalcluessupportingneuro-osteoarthropathyinthiscontextincludemidfootlocationandabsenceofasofttissuewound,whereasthosefavoringosteomyelitisincludepresenceofanoverlyingulcer(especiallyoftheforefootorheel),eitheraloneorsuperimposedonCharcotchanges.4.7.6Ifthefilmsshowclassicchangessuggestiveofosteomyelitis(corticalerosion,periostealreaction,mixedlucency,andsclerosis),andifthereislittlelikelihoodofneuro-osteoarthropathy,itisreasonabletoinitiatetreatmentforpresumptiveosteomyelitis,preferablyafterobtainingappropriatespecimensforculture.4.7.7IftheDiabeticFootCareCentersuspectsacuteCharcotarthropathy,offertreatmentwithanon-removableoff-loadingdevice.Onlyconsidertreatmentwitharemovableoff-loadingdeviceifanon-removabledeviceisnotadvisablebecauseoftheclinicalortheperson’scircumstances.4.7.8DonotofferbisphosphonatestotreatacuteCharcotarthropathy,unlessaspartofaclinicaltrial.4.7.9MonitorthetreatmentofacuteCharcotarthropathyusingclinicalassessment.Thisshouldincludemeasuringfoot–skintemperaturedifferenceandtakingserialX-raysuntiltheacuteCharcotarthropathyresolves.AcuteCharcotarthropathyislikelytoresolvewhenthereisasustainedtemperaturedifferenceoflessthan2degreescentigradebetweenbothfeetandwhenX-raychangesshownofurtherprogression.4.7.10TheDiabeticFootcarecentreshouldcareforpeoplewhohaveafootdeformityresultingfromapreviousCharcot’sarthropathyastheyareathighriskofulceration.
TheDiabeticFoot–QuickReferenceGuideVer.3.0(Draft)
ClinicalPathway3.3-ManagementofCharcot’sFoot
CHARCOT’SFOOT
suspectedwhen Long-standingDiabetes,inthesettingofperipheralSwollenjoint,Redness,neuropathyand/orCKDWarmth&Intactskin
RefertoHigherCentre
X-rayInconclusive HighSuspicion
ConfirmedCharcot’sFoot MRI
Acute Chronic
Off-loading FootUnstable FootStablefor4-6months
Bracing TherapeuticFootwearMonitorforResolutionby Orthosis PatientEducation-serialX-rays Custom-made PeriodicEvaluationto-skintemperaturedifference shoes preventrecurrencebetweenbothlegs ConverttoStableFoot
Oncequiescent,treatasChronic FootremainsUnstable notresponsivetoOff-loadingandImmobilization ConsiderSurgicalStabilization Ulcerrecurs
RemainsUnstableChronicUlceration treatappropriatelyChronicOsteomyelitis asperflowchartofulcerConsiderAMPUTATION
TheDiabeticFoot–QuickReferenceGuideVer.3.0(Draft)
4.8:SURGICALINTERVENTIONSANDREVASCULARIZATION4.8.1Consultasurgicalspecialistinallcasesofdiabeticfootinfectionsthataremoderateorsevere.4.8.2Performurgentsurgicalinterventioninmostcasesofdeepabscesses,compartmentsyndromeandvirtuallyallnecrotizingsofttissueinfections.4.8.3Debrideanywoundthathasnecrotictissueorsurroundingcallus;therequiredproceduremayrangefromminortoextensive.4.8.4Performurgentsurgicalinterventionformostfootinfectionsaccompaniedbygasinthedeepertissues,anabscess,ornecrotizingfasciitis,andlessurgentsurgeryforwoundswithsubstantialnonviabletissueorextensiveboneorjointinvolvement.Additionalnote:Inthosewithanon-severeinfection,carefullyobservingtheeffectivenessofmedicaltherapyandthedemarcationlinebetweennecroticandviabletissuebeforeoperatingmaybeprudent.4.8.5Considersurgicalinterventionincasesofosteomyelitisaccompaniedby:spreadingsofttissueinfection;destroyedsofttissueenvelope;progressivebonedestructiononX-ray;or,boneprotrudingthroughtheulcer.4.8.6Removeslough,necrotictissue&surroundingcalluswithsharpdebridementinpreferencetoothermethods,takingrelativecontraindicationssuchassevereischemiaintoaccount.4.8.7Considerdigitalflexortenotomytopreventatoeulcerwhenconservativetreatmentfailsinahigh-riskpatientwithdiabetes,hammertoesandeitherapre-ulcerativesignoranulceronthetoe.4.8.8ConsiderAchillestendonlengthening,jointarthroplasty,singleorpanmetatarsalheadresectionorosteotomytopreventarecurrentfootulcerwhenconservativetreatmentfailsinahigh-riskpatientwithdiabetesandaplantarfootulcer.ManagementofPeripheralArteryDiseaseinpatientswithDiabeticfootproblems4.8.9Examineapatientwithdiabetesannuallyforthepresenceofperipheralarterydisease(PAD);thisshouldinclude,ataminimum,takingahistoryandpalpatingfootpulses.4.8.10EvaluateapatientwithdiabetesandafootulcerforthepresenceofPAD.Determine,aspartofthisexamination,ankleorpedalDopplerarterialwaveforms;measurebothanklesystolicpressureandsystolicanklebrachialindex(ABI).4.8.11Usebedsidenon-invasiveteststoexcludePAD.Nosinglemodalityhasbeenshowntobeoptimal.MeasuringABI(with<0.9consideredabnormal)isusefulforthedetectionofPAD.TeststhatlargelyexcludePADarethepresenceofABI0.9-1.3,toebrachialindex(TBI)≥0.75andthepresenceoftriphasicpedalDopplerarterialwaveforms.4.8.12Inpatientswithanon-healingulcerwitheitherananklepressure<50mmHgorABI<0.5considerurgentvascularimagingandrevascularisation.
TheDiabeticFoot–QuickReferenceGuideVer.3.0(Draft)
4.8.13ConsidervascularimagingandrevascularisationinallpatientswithafootulcerindiabetesandPAD,irrespectiveoftheresultsofbedsidetests,whentheulcerdoesnotimprovewithin6weeksdespiteoptimalmanagement.4.8.14DonotconsiderDiabeticmicroangiopathytobethecauseofpoorwoundhealinginpatientswithafootulcer.4.8.15Toobtainanatomicalinformationwhenrevascularisationisbeingconsidered,useoneofthesetests-ColourDopplerultrasound,CT-angiography,MR-angiographyorintra-arterialdigitalsubtractionangiography.Evaluatetheentirelowerextremityarterialcirculation,withdetailedvisualizationofbelow-the-kneeandpedalarteries.4.8.16Offerduplexultrasoundasfirst-lineimagingtoallpeoplewithperipheralarterialdiseaseforwhomrevascularizationisbeingconsidered.TakethedecisionofrevascularisationonthebasisofcolourdopplerfindingsanduseDSAfordefiningthevascularanatomypriortotheprocedure.4.8.17Theaimofrevascularisationistorestoredirectflowtoatleastoneofthefootarteries,preferablythearterythatsuppliestheanatomicalregionofthewound,andadequaterevascularizationshouldbeassessedpost-operativelywithacolourDopplerwave-fronts(preferable)orahandheldDopplerprobeusedbedside.4.8.18Acentretreatingpatientswithafootulcerindiabetesshouldhaveliaison/associationwithacentrehavingtheexpertisenecessarytodiagnoseandtreatPAD;bothendovasculartechniquesandbypasssurgeryshouldbeavailable.4.8.19Themultidisciplinaryteamshouldtreatthepatientafterarevascularisationprocedureforafootulcerindiabetes,aspartofacomprehensivecareplan.4.8.20Thereisinadequateevidencetoestablishwhichrevascularisationtechniqueissuperiorandamultidisciplinaryteamshoulddecidethetechniqueofrevascularizationforapatientbasedonanumberofindividualfactors,suchasmorphologicaldistributionofPAD,availabilityofautogenousvein,patientco-morbiditiesandlocalexpertise.4.8.21GiveemergencytreatmenttopatientswithsignsofPADandafootinfectionastheyareatparticularlyhighriskformajorlimbamputation.4.8.22Avoidrevascularisationinpatientsinwhom,fromthepatientperspective,therisk-benefitratiofortheprobabilityofsuccessisunfavourable*.*Explanatorynote:Unfavorableriskbenefitratiowouldindicatethosepatientswhoarefrail,elderly,bedridden,havinglowlifeexpectancy,multipleco-morbiditiesimposinghighriskforsurgicalintervention,etc4.8.23Allpatientswithdiabetesandanischemicfootulcershouldreceiveaggressivecardiovascularriskmanagementincludingsupportforcessationofsmoking,treatmentofhypertensionandprescriptionofastatinaswellaslow-doseaspirinorclopidogrel.4.8.24Donotoffermajoramputationtopeoplewithcriticallimbischaemiaunlessalloptionsforrevascularisationhavebeenconsideredbyavascularmultidisciplinaryteam.Majoramputationwithoutgivingachanceforrevascularizationisindicatedonlyinlifesavingsituationslikefootcausingsepticemia,wetgangrene,orcompletelydestroyedfoot(postcharcot’sorosteomyelitisetc)