The Diabetic foot - Clinical Establishments · limb amputated within two years’ time. People with a history of diabetic foot ulcer have a 40% greater 10-year death rate than people

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


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


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


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)


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)


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


inflammation,followedbyactiontakenbythepatientandcareprovidertoresolvethecauseofinflammation.4.1.8Topreventafirstfootulcerinanat-riskpatientwithdiabetes,provideeducationaimedatimprovingfootcareknowledgeandbehaviour,aswellasencouragingthepatienttoadheretothisfootcareadvice.4.1.9Topreventarecurrentplantarfootulcerinanat-riskpatientwithdiabetes,prescribetherapeuticfootwearthathasademonstratedplantarpressurerelievingeffectduringwalkingandencouragethepatienttowearthisfootwear.4.1.10Topreventarecurrentfootulcerinanat-riskpatientwithdiabetes,provideintegratedfootcare,whichincludesprofessionalfoottreatment,adequatefootwearandeducation.Thisshouldberepeatedorre-evaluatedonceeveryonetothreemonthsasnecessary.


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


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


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.


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


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)


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.


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.


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.


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


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


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.


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).


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.


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


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.


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)


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The Diabetic foot - Clinical Establishments · limb amputated within two years’ time. People with a history of diabetic foot ulcer have a 40% greater 10-year death rate than people