Toenail Onychomycosis – A Canadian Approach with a New Transungal Treatment – a Podiatrist Perspective Alan D Boroditsky, DPM 1 , Anneke Andriessen, PHD 2 1. Vancouver General Hospital, Department of Podiatry, Vancouver, BC, Canada 2. Malden and UMC St Radboud Nijmegen, The Netherlands Introduction Onychomycosis in diabetic patients increases the risk for other foot disorders and limb amputation and is included in diabetic foot ulcer guidelines as one of the risk factors for serious complications that should be screened for. Even though foot examination in diabetes patients is common practice, onychomycosis either goes unnoticed or is left untreated and remains unresolved. Early treatment and intervention including diabetic foot care and education is advisable owing to the progressive nature of fungal infections and the high-risk diabetic foot. Treatment with transungual efinaconazole 10% solution is an effective and safe option for many of these patients. A recently published clinical pathway for toe onychomycosis 1 is used as the basis for the management strategy presented here, and follows a pathway reflective of the therapeutic options available in Canada. Background • Onychomycosis accounts for about half of all nail abnormalities and comprises a third of fungal skin infections. 2 • The prevalence of onychomycosis becomes more common as people age and conditions such as diabetes, peripheral vascular disease, psoriasis and immunosuppression (HIV infection or immunosuppressive therapy) increase in our populations. • Fungal nail disease can coexist with other nail disorders. 2,3,6 • The prevalence of onychomycosis in patients with diabetes has been reported to be 26%. 3-5 • Diabetics appear almost three times as likely to have onychomycosis as non-diabetic individuals. 3-5 • Although there are no studies addressing the relationship between onychomycosis and diabetic foot ulcers, it is possible that one could predispose to the other. 4 • Other factors enhancing the risk for onychomycosis are smoking; avid sports participation; the use of commercial swimming pools; wearing occlusive, tight footwear; use of common, hot, humid climates; and frequent travel to endemic areas. 2 • This common nail infection often results in nail plate damage, deformity and toenail dystrophy that can interfere with walking. 2 • It is also associated with detrimental psychosocial effects. 7 Toe Onychomycosis • Onychomycosis is most frequently caused by dermatophytes (approximately 90% of toenail infections) and non-dermatophyte molds (approximately 6%) that mainly affect toenails (Fig 1). 8,9
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ToenailOnychomycosis–ACanadianApproachwithaNewTransungalTreatment–aPodiatristPerspective
AlanDBoroditsky,DPM1,AnnekeAndriessen,PHD2 1.VancouverGeneralHospital,DepartmentofPodiatry,Vancouver,BC,Canada
2.MaldenandUMCStRadboudNijmegen,TheNetherlands Introduction Onychomycosisindiabeticpatientsincreasestheriskforotherfootdisordersandlimbamputationandisincludedindiabeticfootulcerguidelinesasoneoftheriskfactorsforseriouscomplicationsthatshouldbescreenedfor.Eventhoughfootexaminationindiabetespatientsiscommonpractice,onychomycosiseithergoesunnoticedorisleftuntreatedandremainsunresolved.Earlytreatmentandinterventionincludingdiabeticfootcareandeducationisadvisableowingtotheprogressivenatureoffungalinfectionsandthehigh-riskdiabeticfoot.Treatmentwithtransungualefinaconazole10%solutionisaneffectiveandsafeoptionformanyofthesepatients.Arecentlypublishedclinicalpathwayfortoeonychomycosis1isusedasthebasisforthemanagementstrategypresentedhere,andfollowsapathwayreflectiveofthetherapeuticoptionsavailableinCanada. Background
• Onychomycosisaccountsforabouthalfofallnailabnormalitiesandcomprisesathirdoffungalskininfections.2
• Theprevalenceofonychomycosisbecomesmorecommonaspeopleageandconditionssuchasdiabetes,peripheralvasculardisease,psoriasisandimmunosuppression(HIVinfectionorimmunosuppressivetherapy)increaseinourpopulations.
• Fungalnaildiseasecancoexistwithothernaildisorders.2,3,6 • Theprevalenceofonychomycosisinpatientswithdiabeteshasbeenreportedtobe
26%.3-5• Diabeticsappearalmostthreetimesaslikelytohaveonychomycosisasnon-diabetic
individuals.3-5• Althoughtherearenostudiesaddressingtherelationshipbetweenonychomycosisand
diabeticfootulcers,itispossiblethatonecouldpredisposetotheother.4• Otherfactorsenhancingtheriskforonychomycosisaresmoking;avidsports
participation;theuseofcommercialswimmingpools;wearingocclusive,tightfootwear;useofcommon,hot,humidclimates;andfrequenttraveltoendemicareas.2
• Thiscommonnailinfectionoftenresultsinnailplatedamage,deformityandtoenaildystrophythatcaninterferewithwalking.2
• Itisalsoassociatedwithdetrimentalpsychosocialeffects.7 ToeOnychomycosis
• Onychomycosisismostfrequentlycausedbydermatophytes(approximately90%oftoenailinfections)andnon-dermatophytemolds(approximately6%)thatmainlyaffecttoenails(Fig1).8,9
• Onychomycosismaypresentwithfourpatternsofinvolvement.1Mostcommonisadistalsubungalpattern,whereproximalsubungalpresentationisrareandoftenindicatesimmunodeficiency.1Yeastinfectionsmaypresentasasuperficialwhitepatternandcanbetreatedtopically.1Inadvanceddiseasethewholenailplatemaybeinvolved,makingtheconditionlessresponsivetotherapy.1
Fig1:Toeonychomycosis:Mild-distal-lateralsubungual
• Onychomycosisisaseriousconditioninpeoplewithdiabetesandincreasestheirriskforotherfootdisordersandlimbamputation(Fig2aand2b).11,12,15,16,20
• Onychomycosiswilloftenresultinthickenedanddystrophicnailsthataredifficulttomanageformanypatientsbecauseoftentheycan’treach,see,feelorhavethestrengthordexteritytocuttheirnails.12Theresultisthatthenailsgounmanagedandprovideasignificantandoftenoverlookedareaofriskforlowerextremityinfectionandlimbloss.11,12
• Manydiabeticpatientshavelossofprotectivesensationthatwillresultintheirinabilitytofeelanyofthewarningsignsofinfectionintheirfeet.
• Advancedperipheralneuropathywillalsoleadtomotorneuropathyresultinginanimbalanceofthestabilizingmusclesofthefootcausingdeformitysuchasdigitaloverlapandhammertoes,assignificantprecursorstofungalinfectionsandulcerations.12,15,16
• Asimpleingrownnailoralessertoedeformitythatcausesthenailtorubintotheadjacenttoecaneasilyandtoooftencausecellulitisorosteomyelitisoftheunderlyingbone.12
• Brokenskinprovidesaportalforbacteriaandoftenwillstartthecascadeofdiabeticfootcomplications.12
• Earlytreatmentandinterventionincludingdiabeticprophylacticfootcareeducationisadvisableowingtotheprogressivenatureoffungalinfectionsandthehighriskdiabeticfoot.12,15,16
• Thelongcourseoftreatmentforonychomycosis,togetherwiththeexistingpolypharmacyindiabeticpatientsmayleadtomonetarychallengesandpotentialsideeffects.
Fig2a:Prevalenceoftoeonychomycosis20 Fig2b:HigherIncidenceofsecondaryinfectionsinpatientswithdiabetes Assessment
• Diagnosisofonychomycosisisbasedonclinicalpresentationandtestresults.1Astherearemanydisordersthatcausenailchanges,objectiveassessmentmayhelpclarifytheaetiology.
• Apracticalapproachmaybetotreattopicallybeforetestingorwhilewaitingfortestresults.1Inclinicalpractice,treatmentisoftenbegunwithoutconfirmationoftestresults.Apositivepotassiumhydroxidemicroscopicorcultureforfungusshouldbeperformedbeforeconsideringusingsystemicantifungaltherapy.1,8-9,14
• Fungalinfectionmayalsoexistwithotherdisorders(e.g.psoriasis/pincernails)andsuccessfultreatmentofthefunguswillnotcleartheco-existingdisorder.1
Thefollowing1maybereviewedwhenapatientpresentswithonychomycosis:
• Investigatepatienthistoryandwhattreatmenthasbeenutilized.• Checkifthereisanincidentalfindingofonychomycosis.• Establishthepatient’spastmedicalhistoryincludingage(isthepatientelderly),
comorbiditiessuchasdiabetes,cancerandrenaldisease.
• Checkifthepatientisimmuno-suppressedorhasaninflammatoryskindiseasesuchaspsoriasis.
• Establishifthereisahistoryoffunguselsewhere,e.g.Tineapedis.• Discusstherecreationalhabitsofthepatientincludingtheirhygiene,environment
andathleticwear.• Establishthepatient’sfootcaremaintenanceincludingspa’s,self-debridementor
pedicures.• Patientpsychologicalwelfareisanotherimportantareaforassessment,with
concernsaroundhowthediseaseimpactstheirlifestyle.Askpatientsiftheyareembarrassedabouttheircondition,ifthevisittotheclinicwastheirowninitiative,andiftheyareengagedandinformedintheirhealthcarechoices.
• Beforeconsideringtreatment,itisimportanttodiscusspatientexpectationsoftreatmentoutcomes.1Thephysicianmustbeabletodiscussalloptionsandroadblocksthatarecommonwithonychomycosistreatment.
TreatmentforToeOnychomycosis
• Arecentlypublishedclinicalpathwayforthepreventionandtreatmentoftoeonychomycosis1wasmodifiedforusebypodiatristsandchiropodistsandaddressesthefollowingsteps:aetiologyanddifferentialdiagnosis,prevention,treatment,evaluationandmaintenancestrategies(Fig3).
• Beforeinitiatingtreatment,patientsshouldbeinformedaboutstepstheycantaketocontaintheinfectionandpreventrecurrence,suchas.foothygiene,useofshowersandalsandregularmedicalpedicures.1
• Oftenpatientspresentwithalonghistoryoftryingamyriadofhomeremedies.Whenrecommendingtreatment
• t,prosandconsofvariousavailableoptionsmaybediscussed.1• PatientsmayhavesearchedtheInternetforinformationandoftenhaveconcerns
regardingtreatmentstheyhavereadabout,suchasoralantifungalandhepaticinvolvement,andvariousdrug-interactions.
• Patientsmayhaveheardaboutlasertreatmentsandmaybeconcernedaboutcost,sideeffects,efficacyandthepossibilityofinfectionreoccurrence.
• Ifthepatientdoesnotrespondtotreatment,microscopicorcultureconfirmationisneededbeforeproceedingtooraltherapy.1,8-9,14
SystemicTreatment • Oraltreatmentisthegoldstandardfortoeonychomycosiswithmorethan60%nail
plateinvolvement.8,13ThetwooptionsavailableareItraconazole(Sporanoxitraconazole),JanssenPharmaceuticalsInc,Titusville,NJ)andterbinafine(Lamisil(terbinafineHCl),NovartisPharmaceuticalsCorporation,EastHanover,NJ).
• Thereareissuestobeconsideredwhenprescribingsystemictreatment,suchasdruginteractions,hepatotoxicity,safetyconcernsandtheneedformonitoring.8
• Studiesoforaltreatmentthatevaluatedmycologiccureatweek48,definedasnegativeKOHandnegativeculture,8showedterbinafineHCltobemoreeffective,witha70%
healingrateversus54%withitraconazole.Forcompletecurerates,terbinafinewasequallymoreeffective,with38%completecureversus14%foritraconazole.8
• Fig3:PathwaytothePreventionandTreatmentofToeOnychomycosis TopicalTreatment
• Topicalnailpreparationsareindicatedfordistalsubungalandsuperficialwhitepatternsofnailonychomycosis.1,10
• Sometopicalantifungalagentsactasalacquerappliedtothenailsurface(e.g.Penlaclacquerwiththeantifungalciclopirox).8,19Thisspecifictopicaltreatmentshouldbecombinedwithselectivedebridementofthenail,toenablepenetration.19
• Newertopicalortransungalagentshavetheabilitytopenetratenailkeratin.10• Thenon-laquertransungaltreatmentcontainingefinaconazole10%solutionhas
demonstratedclinicaleffectivenesswhenappliedasmonotherapyinpatientswithmild-to-moderatetoeonychomycosis.10Theprimaryefficacyendpoints(completeclinicalcureandmycologiccure)weresignificantlygreaterthanvehicleatweek52(p<0.001)andclinicalimprovementcontinuedaftertreatmentwasstopped(week48).10
LaserTreatment • Lasermaybeusedforthetreatmentofonychomycosiswithanemphasisonclinical
improvementofthenail.17,18• Protocolsincludedebridementofthenail,followedbylasertherapy5-7times,with
morepasses(notincreasingjoules)todisruptfungussepsis.17,18• Treatmentwithlasermaytake3-4monthsormore.17,18• Theefficacyoflasertherapyisasubjectofdebateandcurrentlyresearchhasnot
demonstratedsustainedefficacy.18• Ithasbecomecommonpracticetoadoptauniversalfootcareapproachforthe
utilizationoflasertherapy,whichincludesaddressingconcomitantTineapedisinfections,hygiene,shoegearandsockchanges,andhabitchangesincludingawarenessofenvironmentalfactorssuchasgymorlockerroomfloorcontamination.
• Thepatientmustbeeducatedaboutfootcareduetothehighchanceofrecurrenceandmustnotrelysolelyononetreatmentmodality.
Conclusion
• Alargepopulationofonychomycosispatientsareseeninpodiatristandchiropodistsoffices,1,15andtheincidenceisincreasingparticularlyamongyoung,elderlyanddiabeticpatients.2,4
• Diabeticfootulcerguidelinesidentifyonychomycosisasahigh-riskfactorforcomplications,evenamputation.12Earlydiabeticfootexaminationshouldincludescreeningforonychomycosis.
• Adiabeticfootexamwillincludeadermatologicalevaluation,vascularassessment,neurologicalevaluationandbiomechanicalreview11,12,15,16toidentifytheassociatedriskfactorsandenableaccuratecategorizationofthepatient’scondition(e.g.low,mediumorhigh-riskstatus).12
• Eventhoughfootexaminationindiabeticpatientsiscommonpractice,onychomycosiseithergoesunnoticedorisleftuntreatedandremainsunresolvedinmanypatients.Itisimperativethatpatientsbeengagedindiabeticfooteducation.
• Theinformationobtainedenablesthephysiciantodevelopaneffectiveplanforpreventionandtreatment.
• Thegoalofmanagementistoeducatethepatient,assessriskfactorsandmanagethoserisksinaprophylacticmanner.12,15
• Healthcareprovidersmustbeawareofpatientbarriersregardingtreatmentandfootcare.Tothatend,itisquitecommontoincludethefamilyorcaregiversinconversationsconcerningriskfactorsandfootcareforinpatientswithdiabetes.
• Efinaconazolesolutioniseffectiveinpatientsthathavemildtomoderateonychomycosis1wherethenailislessthan60%involvedandlessthan3nailsintotalareinvolved.Moreover,itisagoodoptionwhensystemiconychomycosistreatmentiscontraindicated.1
• Transungualonychomycosistreatmenthasbenefitsoversystemictreatmentasbothpatientsandcliniciansprefertoavoidsystemicsideeffectsandtheneedformonitoring.17
• Whenusingatopicalagent,thepropertiesofnailplate–thicknessandtherelativecompactstructureofthenail–mustbeaddressed.
• Alimitationassociatedwithusingtopicallacquertreatmentsisthenecessityoffrequentnaildebridementtoenabletreatmentpenetration.19
• Efinaconazole10%solutionisanon-lacqueralcohol-basedformulationthathasalowmolecularweightandbindswithkeratin.10Theproductiseasytoadminister,withaplasticsqueezebottlewithaflow-throughbrushusedforapplication.1,10
• Althoughthetransungualefinaconazole10%solutiondoesnotrequiredebridementtobeeffectiveinindividualswithonychomycosis,high-riskdiabeticfootpatientsdorequireassessment,dailyobservationandpossiblynaildebridement.12
• Treatmentthatcanbetopicallyappliedshouldbeoffered.12,15• Whenonychomycosisistreatedearlywithefinaconazolesolution,complicationsmaybe
avoided,includingtheseriousandcostlyoutcomeoflimbsalvage.10,12• Itisimperativethatpreventionmeasuresbetakentoreducetheriskof
recurrence.Thesemeasuresinclude,butarenotlimitedtolifestylemodifications(avoidbeingbarefootinhighareasofcontagion),sanitizationofshoesandsocks,regularfollowupandperiodicfootexams,treattineapedisandtreattoenailspreviouslyinfectedorreinfectedwithtopicalmedication.
References
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