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w w w . r b o . o r g . b r

Original

Article

Prevention

of

lower-limb

lesions

and

reduction

of

morbidity

in

diabetic

patients

,

夽夽

Antônio

Homem

do

Amaral

Júnior

a

,

Leonã

Aparecido

Homem

do

Amaral

a,∗

,

Marcus

Gomes

Bastos

a

,

Luciana

Campissi

do

Nascimento

a

,

Marcio

José

Martins

Alves

a

,

Marco

Antonio

Percope

de

Andrade

b

aUniversidadeFederaldeJuizdeFora(UFJF),JuizdeFora,MG,Brazil

bSchoolofMedicine,UniversidadeFederaldeMinasGerais(UFMG),BeloHorizonte,MG,Brazil

a

r

t

i

c

l

e

i

n

f

o

Articlehistory:

Received20June2013 Accepted23August2013 Availableonline4July2014

Keywords:

Diabetesmellitus Primaryprevention Foot

Diabeticneuropathies Peripheralvasculardiseases Infection

Ulcer Amputation

a

b

s

t

r

a

c

t

Objective:Toassesstheimpactofadiabeticfootoutpatientcliniconreducingthemorbidity

ofthisdisease,withemphasisonlower-limblesions.

Methods:Thiswasaprospectiveobservationalstudywithatargetpopulationof30cases

outofatotalof77patientsinthediabeticfootoutpatientclinic.Theinclusioncriterionwas thatdatarelatingtolaboratorytests,clinicalexaminations,neuropathicandvasculartests andtheelbow-armindexneededtobeavailablefromallthepatients,withrepetitionafter 18monthsoffollow-up,soastoanalyzetheirevolution.Thestatisticalanalysiswasdone usingtheMcNemarchi-squaretestfordependentsamples.

Results:Thepatients’meanagewas61years.Allofthemhadtype2diabetesmellitus(DM),

whichhadstarted14.5yearspreviously,onaverage,and20%hadneuropathies.After18 months,therewasnochangeinthefrequencyoflesionsindiabetestargetorgans(p=1.000) orintheneuropathyrate(p=1.000).However,thereweresignificantimprovementsin neu-ropathicsymptoms,from70%to36.7%(p=0.035),andinperipheralarterialdisease,from 73.3%to46.7%(p=0.021).Therewasalsoadecreaseinulcersfrom13.3%to10%(p=1.000).

Conclusions:Creationofspecializedoutpatientclinicsforpreventionofdiabeticfootisa

viableinvestment,whichhaslowcostcomparedwiththehighcostsgeneratedthroughthe complicationsfromthisdisease.Thisapproachnoticeablyimprovesthepatients’qualityof life,withreductionofmorbidity.

©2014SociedadeBrasileiradeOrtopediaeTraumatologia.PublishedbyElsevierEditora Ltda.Allrightsreserved.

Pleasecitethisarticleas:doAmaralJúniorAH,doAmaralLAH,BastosMG,doNascimentoLC,AlvesMJM,deAndradeMAPetal. Prevenc¸ãodelesõesdemembrosinferioresereduc¸ãodamorbidadeempacientesdiabéticos.RevBrasOrtop.2014;49(5):482–7.

夽夽

WorkperformedattheMinasGeraisInstituteforNephrologyStudyandResearch(IMEPEN),whichislinkedtotheSchoolofMedicine, UniversidadeFederaldeJuizdeFora(UFJF),JuizdeFora,MG,Brazil.

Correspondingauthor.

E-mail:leonanamaral@yahoo.com.br(L.A.H.doAmaral). http://dx.doi.org/10.1016/j.rboe.2014.06.001

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Prevenc¸ão

de

lesões

de

membros

inferiores

e

reduc¸ão

da

morbidade

em

pacientes

diabéticos

Palavras-chave:

Diabetesmellitus

Prevenc¸ãoprimária Pé

Neuropatiasdiabéticas Doenc¸asvascularesperiféricas Infecc¸ão

Úlcera Amputac¸ão

r

e

s

u

m

o

Objetivo:Avaliaroimpactodeumambulatóriodepédiabéticonareduc¸ãodamorbidadeda

doenc¸a,comênfasenaslesõesdosmembrosinferiores.

Métodos: Estudo prospectivo, observacional, compopulac¸ão alvo de 30 casos do total

de77 pacientesdoambulatóriodepédiabético.Ocritériodeinclusãofoiquetodosos pacientestivessemexameslaboratoriais,exameclínico,testesneuropáticoevasculare índicetornozelo-brac¸orepetidosapós18mesesdeacompanhamento,oquepermitiu anal-isarsuaevoluc¸ão.Aanáliseestatísticafoifeitacomotestequi-quadradodeMacNemarpara amostrasdependentes.

Resultados: Amédiadeidadedospacientesfoide61anos,todosportadoresdediabetes

mellitus(DM)tipo2,iniciadaemmédiahavia14.5anos,e20%eramneuropatas.Após18

meses,nãohouvemudanc¸anafrequênciadelesãoemórgãoalvodadiabetes(p=1000) enoíndicedeneuropatia(p=1000).Obteve-se,noentanto,melhoriasignificativados sin-tomasneuropáticosde70%para36.7%(p=0.035),bemcomodadoenc¸aarterialperiféricade 73.3%para46.7%(p=0.021).Foiobservadaaindadiminuic¸ãode13.3%para10%dasúlceras (p=1000).

Conclusões: Acriac¸ão deambulatórios especializados em prevenc¸ãodopé diabético é

investimentoviável,de baixocustoquando comparadoaosaltoscustos geradospelas complicac¸õesdessadoenc¸a.Essaabordagemmelhorasensivelmenteaqualidadedevida dopaciente,comareduc¸ãodamorbidade.

©2014SociedadeBrasileiradeOrtopediaeTraumatologia.PublicadoporElsevier EditoraLtda.Todososdireitosreservados.

Introduction

Diabetes mellitus (DM) causes degenerative complications that have human and socioeconomic repercussions and havebecomeanimportantpublic healthproblem.1 Among

these complications are lesions in target organs, includ-ingretinopathy,nephropathyandacceleratedatherosclerosis, withincreasedrisksofmyocardialinfarctionorstroke,and lesionsthataffectthefeet,whicharethemostfrequenttype.2

According tothe definition ofthe International Consensus onDiabeticFoot, thiscondition isunderstood toconsistof infection,ulcerationand/ordestructionofthedeeptissues, inassociation with neurologicalabnormalities and various degreesofperipheralvascular disease inthe lower limbs.2

Theprevalenceofulcers onthe feet of the diabetic popu-lationis between4%and 10%,and 85% ofamputations of the lower extremities among these patients are preceded byulceration.2 Approximately 40–60%of all non-traumatic

amputations ofthe lower limbsare performed on diabetic patients.1,2 Threeyearsafteramputationofalower limbof

adiabetic individual,the percentagesurvivalis50%,while overafive-yearperiod,themortalityraterangesfrom39%to 68%.3

Oneveryimportantfactorrelatingtodevelopmentofulcers onthefeetisthepresenceofperipheralmotor-sensory neu-ropathy,whichhasbeen associatedwithlossofsensitivity topainandlossofperceptionofpressure,temperatureand proprioception.4–8 This leads to diminished perception of

woundsortrauma.Fouroutofeveryfiveulcersondiabetic individualsareprecipitatedbyexternaltrauma.2Furthermore,

motorneuropathygivesrisetoatrophyandweakeningofthe intrinsicmusclesofthefeetandgeneratesdeformitiessuch ascrookedtoesandabnormalgaitpatterns,whichevolveto calluses andpressure ulcers.Casesofgreater severitylead toCharcotfoot,whichisaprogressivediseasecharacterized byjointdisplacement,pathologicalfracturesanddebilitating deformities.8,9Autonomicneuropathyalsoleadstoreduction

ortotalabsenceofsudoriparoussecretionandleadstoskin desiccation,withcracksandfissures.8,10

Peripheral vascular disease (PVD) is an important risk factor for ulceration and amputation.6,11–13 It resultsfrom

atherosclerosisofperipheralarteries,leadstoobstructionof distalarteriesandarterioles,hindersbloodflowanddeprives the tissues ofadequate supplies of oxygen, nutrients and antibiotics, which impairs ulcer healing and may conse-quently lead to gangrene.14 Gangrene is four times more

commonamongindividualswithdiabetesthaninthegeneral population,anditsincidencegraduallyincreaseswithageand withthedurationofthedisease.15

Ulcers generally result from trivial, mild and repeated trauma,suchaserroneousfitanduseoffootwear,orevenfrom walkingbarefoot.8,12Approximately70–100%ofulcerspresent

signsofperipheralneuropathywithvaryingdegreesofPVD. Infectionisonlyrarelyconsideredtobethedirectcauseof anulcer.16However,infectedulcerspresentahigherriskof

subsequentamputation.2

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adequate treatment.1,17,18 With thisaim inmind,an

inter-disciplinarycareprogramfordiabetics(PAID)wasstartedin January2006,bythehypertension,diabetesandobesity con-trolclinicofthemunicipalhealthdepartmentofthecitywhere thisstudywasconducted.Thisprogrampromotesspecialized multidisciplinaryfollow-upfordiabeticpatientsandaimsto educatepatientsandtoimplementpreventionandearly diag-nosisandtreatmentoflesionsintargetorgans.

Objective

ToevaluatetheimpactofthePAIDdiabetic footoutpatient clinicforreducing morbidityamongdiabeticpatients, with emphasisonlower-limblesions.

Materials

and

methods

Thepresentstudywasapprovedbytheinstitution’sresearch ethics committee under protocol no. 1437.128.2008. It had supportfromtheNationalCouncilforScientificand Techno-logicalDevelopment(CNPq)throughitsinstitutionalprogram forscientificinitiationbursaries.Thiswasaprospective obser-vationalstudyoncases,withatargetpopulationformedby30 ofthe77patientsofthePAIDdiabeticfootoutpatientclinic. These patients were recruited spontaneously amongthose who,byApril2011,after18monthsoffollow-up,had under-gonecompleterepetitionoftheirinitialclinicalandlaboratory tests.

Theparticipantsinthisstudywereovertheageof18years, withoutdistinctionregardingsexorethnicity.Theywerefree torefusetoparticipateatanytime,withoutanymodification inthewayinwhichtheywereattendedbytheresearcher. Con-fidentialityandprivacywereguaranteed.Afreeandinformed consentstatementwassignedbyallparticipants.

All individuals who did not agree to participate were excluded, aswere all those who didnot participateinthe entireclinicalandlaboratoryreevaluationperformedafter18 monthsoffollow-up.

ThemultiprofessionalPAIDteamiscomposedofavascular surgeon,anendocrinologist,adermatologist,anephrologist,a psychologistandanutritionist.Allthepatientswerefollowed upand were referredtocardiologists,orthopedistsor oph-thalmologistsworkingforthemunicipalauthority,whenever necessary.

DescriptionofthefunctioningofthePAIDdiabeticfoot out-patientclinic:

1. Initial medical evaluation, with peripheral neurologi-cal clinical tests (diabetic neuropathy was classified in accordancewiththePortuguese-languageversionsofthe NeuropathicSymptomScoreandNeuropathicImpairment ScoredevisedbyMoreiraet al.19)andarterialevaluation

bymeansoftheankle-brachialindex(ABI)(systolic arte-rialpressureoftheankledivided bythe systolicarterial pressureofthe arm,bothmeasured withthepatient in thesupineposition,usingaportableDopplerdevice).2

Rep-etitionoftheneurologicalandvasculartests18 months later.

2. Laboratorytests.

3. Return visits were scheduled in accordance with the international diabetic foot consensus and the practical guidelinesformanagementandpreventionofdiabeticfoot (2007): annual returns, if neuropathy was absent; half-yearlyreturns,ifneuropathywaspresent;three-monthly returns, if neuropathy was present in association with signsofperipheralvasculardiseaseand/ordeformitiesof thefeet;orbetweeneveryoneandthreemonthsincases ofamputationorpreviousulceration.1

4. Thepatientsweresystematicallyadvisedregardingcareto betakenforavoidinglesionformation.Forthis,talkswere givenperiodically,leafletsweredistributedandguidance wasgivenduringconsultations.

5. Thewoundsweretreatedonanoutpatientbasis.Incases ofinfectedwoundsthatweregreaterthan2cmindiameter orshowedclinicalsignsofsepsis,thepatientsweresentto areferralhospital.

The data were entered into the Epi Info software (ver-sion 3.5.1). Statistical comparisons were made using the McNemarchi-squaretestfordependentsamples,whenthe variables were categorical; orusing the Student’st testfor dependent samples, whenthe variables were ofnumerical type.P-values<0.05 wereconsideredsignificant.The statis-ticalanalysiswasperformedusingtheSPSSsoftware,version 15.

Results

Seventy-sevenpatientsparticipatedinthefirstevaluationof thestudy,onthedaywhentheywerefirstregisteredatthe outpatientclinic.Therewere33males(42.9%)and44females (57.1%).Ofthese,30underwentcompleterepetitionofthe ini-tialsetofneurologicalandvasculartestsandlaboratorytests, after18monthsoffollow-up.

Thirteenoftheseweremale(43.3%)and17were female (56.7%), and all of them presented type 2 DM, which had started on average 14.5 years earlier. The patients’ mean age was 61 years and the standard deviation was 9.01.

At the first evaluation, four patients (13.3%) were seen tohaveundergonepreviousamputation.Amputationofthe fourth toe ofthe right footofonepatient wasseen atthe secondevaluation.

Sometypeoflesioninatargetorgan(heart,kidney,retina or microvasculature of the feet) was seen in 90% of the patients, andthe frequencyofthis didnotchangeafter18 months(p=1.000).Theratesofcardiacdiseases(40%;n=12) and renal diseases (23.3%; n=7) did not change (p=1.000), while retinopathy showed a non-significant increase from 53.3% (n=16) to 63.3% (n=19) (p=0.453). Furthermore, the patients did not present any occurrences of stroke and/or acutemyocardialinfarctionoverthisperiod.

Tables1–6presenttheresultsrelatingtothedataevaluated inthisstudy.

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Table1–Perceptionofthecapacityforself-careofthefeet(n=30).

Firstevaluation Secondevaluation p

AbFr RFr(%) AbFr RFr(%)

Fullself-care 22 73.3 12 40.0 0.004

Partialself-care 7 23.3 17 56.7

Inabilitytoperformself-care 1 3.3 1 3.3

AbFr=absolutefraction;RFr=relativefraction.

Table2–Clinicalexaminationsonthefeet(n=30).

Firstevaluation Secondevaluation p

AbFr RFr(%) AbFr RFr(%)

Previousulcer 14 46.7 15 50.0 1.000

Amputation 4 13.3 5 16.7 1.000

Deformityofthefeet 6 20.0 6 20.0 1.000

Nailmycosis 19 63.3 15 50.0 0.125

Mycosisbetweentoes 14 46.7 5 16.7 0.012

Activeulcer 4 13.3 3 10.0 1.000

Cracks 3 10.0 3 10.0 1.000

Useofappropriatefootwear 14 46.7 25 83.3 0.013

Table3–Neuropathicsignscore19(n=30).

Firstevaluation Secondevaluation p

AbFr RFr(%) AbFr RFr(%) p=0.102

Normal 24 80.0 19 63.3

Mild 3 10.0 7 23.3

Moderate 3 10.0 4 13.3

Table4–Neuropathicimpairmentsymptomscore19(n=30).

Firstevaluation Secondevaluation p

AbFr RFr(%) AbFr RFr(%) p=0.035

Normal 3 10.0 8 26.7

Mild 6 20.0 11 36.7

Moderate 17 56.7 7 23.3

Severe 4 13.3 4 13.3

Table5–DiagnosisofdiabeticneuropathyaccordingtothecombinationindicatedbyMoreiraetal.19betweenthe neuropathicsymptomscoreandtheneuropathicimpairmentscore(p=1.000).

Firstevaluation Secondevaluation p

AbFr RFr(%) AbFr RFr(%) p=1.000

Neuropathicpatients 6 20.0 6 20.0

Non-neuropathicpatients 24 80.0 24 80.0

Table6–Peripheralarterialdiseasebasedontheankle-brachialindex(ABI)(n=30).

Firstevaluation Secondevaluation p

AbFr RFr(%) AbFr RFr(%)

Normal:0.91–1.30 8 26.7 13 43.3 0.129

Mildobstruction:0.70–0.90 8 26.7 6 20.0

Moderateobstruction:0.40–0.69 8 26.7 5 16.7

Poorlyreduced:>1.30 6 20.0 6 20.0

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Discussion

It has been well established that 85% of the problems resultingfrom diabetic foot canbepresentedthrough spe-cialized care2,7,8,12,20,21 and that up to 50% ofamputations

and ulcerations can be presented through early diagnosis and appropriate treatment.1,17,18 Identification and

classi-fication of patients who are at risk (such as those with diabeticneuropathy,peripheralarterialdiseaseandstructural deformities),2earlyaggressivetreatmentandindividual,

fam-ilyandcommunityeducationformasolidbasisforpreventing limbamputation.22TheseactionsweretargetedinthePAID

diabeticfootoutpatientclinic.

Outofthe30patientswhoparticipatedinthestudy,90% presentedsometypeoflesioninatargetorgan(heart,kidney, retinaormicrovasculatureofthefeet),andthefrequencyof theselesionsremainedunchanged18monthslater(p=1.000). Thisshowsthatcaringforthewholepatientshouldformpart oftheapproach.23

After 18 months of follow-up at the PAID diabetic foot outpatient clinic, the perception regarding the full condi-tions of self-care of the feet (Table 1) varied from 73.3% atthe first evaluation to 40% at the second, and the per-ception regarding the capacity for partial self-care varied from23.3%to56.7%,whichindicatesthatasignificant num-ber of patients (p=0.004) perceived that they would need specializedfollow-upinordertoreceivetheappropriate pre-ventiveand/orcurativetreatment.Diabeticpatientswhodo notadheretotheirtreatmenthavea50-foldgreaterchanceof ulcerationofthefootanda20-foldgreaterchanceofhaving toundergoamputationthanthosewhofollowtheguidance correctly.24Onestudydemonstratedthat22outof23

ampu-tationsbelowthekneewereperformedonpatientswhohad neverreceivedanyinformationabouttherapeuticcareor pre-ventivemeasures.2

Atthe startofthe follow-up,46.7%ofthepatientswere using appropriate footwear. Eighteen months later, 83.3% were using appropriatefootwear (p=0.013) (Table 2). Inap-propriatefootwearpredisposesthefeet toextrinsictrauma and is considered to be a precipitating factor for ulcera-tion of the feet.25 Many studies have demonstrated that

when protective footwear is available, prevention of ulcer recurrenceisachievedin60–85%ofthepatients.2Theideal

footwear reduces the pressure on the feet to below the threshold for ulceration. Footwear and its insoles should be inspected frequently and exchanged when necessary. If the footwear that is habitually used cannot be adapted because oforthopedicdeformitiesor lesionsdue to exces-sivecontactarea,manufactureofspecialfootwearshouldbe indicated.5,8,11,13,21

After18 months, the rate ofmycosis between the toes hadreducedfrom46.7%to16.7%(p=0.012),nailmycosishad diminishedfrom63.3%to50%(p=0.125)andthecrackrate remainedat10%(Table2).Inonestudy,mycosisbetweenthe toeswasconsideredtoberesponsiblefor20.8%oftheulcers ofthefeet,onychomycosisfor52.5%,callusesandcracksfor 49.5%,driedandflakingskinfor63.4%and nailcleanliness and impropernail cuttingfor 73.3%.26 Basic hygiene

mea-sures such as properly washing the feet and drying them

carefully,usinghydratingcreamoroilandcuttingthenails properly and not excessively closely (tobe done by a chi-ropodist)avoidstheappearanceofthesetriggeringfactorsfor diabetic foot,and suchmeasuresare systematically imple-mentedatPAID.27

Intheinitialevaluation,13.3%ofthepatientshadahistory ofamputationand46.7%hadpreviouslyhadanulcer,which hadbeencured(Table2).Thisisahighnumberofpatientswith historiesofhighriskofamputationaccordingtotherisk clas-sificationoftheinternationaldiabeticfootconsensus.1Over

the18-monthfollow-up,thenumberofpatientswithactive ulcers decreased from four (13.3%)to three (10.0%), which demonstratesthattheobjectiveofpreventingtheappearance ofnewulcerswasachieved.Afterthese18months,itwasseen thatonlyoneamputationhadbeenperformed:thefourthtoe oftherightfootofonepatient(3.4%).Thus,thefinal evalu-ationshowedthatfivepatientshadhistoriesofamputation (16.7%).Thiswasanexcellentresult,incomparisonwiththe literature,inwhichamputationratesofaround43–85%have been reportedamongpatientsundergoingmultidisciplinary approaches.1,2,12

Inmakingthediagnosisofneuropathy,whichisan impor-tantriskfactorfordevelopmentofulcerationonthefeet,2,4–8

thecriteriaofMoreiraetal.19wereused(Tables3–5).AtPAID,

20% ofthe patients presented neuropathies (Table 5), and this proportion did notincrease over the 18-monthperiod (p=1.000).Thisfindingisimportant,giventhatwhen periph-eral neuropathy becomes established, it is irreversible.28,29

Therefore,itisimportantforindividualswitharecent diag-nosis to have adequate control over the risk factors, and for prophylaxisto beimplemented for individuals without risk factors, such as rigorous control over blood glucose levels, guidance regarding smoking and alcohol consump-tion,andcontroloverarterialhypertension,dyslipidemiaand vasculopathy.30

With the treatment implemented at PAID, significant improvements in the symptoms of peripheral neuropathy wereobserved(p=0.035)(Table4).Therewasadeclineinthe proportion ofpatientswith moderate tosevere symptoms, from 70% to36.7% over the18-month period.There wasa non-significantdecreaseinthenumberofpatientswithsigns ofdiabeticneuropathyatnormallevels,from 80%to63.3% (p=0.102)(Table3),whichshowsthatitwaseasiertoreverse thesymptoms(whichreflectanearlierstageofneuropathy) than the signs (whichrepresent amoreadvanced stageof neuropathy).19

Distalperfusionisanotherimportantriskfactorfor ulcer-ationandamputation.2,6,11–13 Overthe18-monthperiod,our

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Conclusion

Creation of diabetic foot prevention and control programs within the primary and secondary healthcaresectors is a viableinvestment,givenitslowcost,inviewoftheimportant humanandsocioeconomicrepercussionsofthedisease.This hasapositiveimpactthroughnoticeablyimprovingpatients’ quality of life and reducing the vascular and neuropathic symptomsandoccurrencesofulcerationandamputation.

Funding

Pro-RectorateforResearch,FederalUniversityofJuizdeFora (PROPESQ).

Institutional Program for Scientific Initiation Bursaries (PIBICCNPq/UFJF).

Conflicts

of

interest

Theauthorsdeclarethattherewerenoconflictsofinterest.

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De-La-Torre-Ugarte-GuaniloMC,PaceAE.Caracterizac¸ãode pessoascomdiabetesemunidadesdeatenc¸ãoprimáriae secundáriaemrelac¸ãoafatoresdesencadeantesdopé diabético.ActaPaulEnferm.2006;19(3):296–303. 27.Ochoa-VigoK,PaceAE.Pédiabético:estratégiaspara

prevenc¸ão.ActaPaulEnferm.2005;18(1):100–9. 28.BoikeAM,HallJO.Apracticalguideforexaminingand

treatingthediabeticfoot.CleveClinJMed.2002;69(4):342–8. 29.LiatisS,MarinouK,TentolourisN,PagoniS,KatsilambrosN.

Usefulnessofanewindicatortestforthediagnosisof peripheralandautonomicneuropathyinpatientswith diabetesmellitus.DiabMed.2007;24(12):1375–80.

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Table 1 – Perception of the capacity for self-care of the feet (n = 30).

Referências

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