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  1. 1. The Diabetic Foot Syndrome,diagnosis and consequences
  2. 2. RIJKSUNIVERSITEIT GRONINGEN The Diabetic Foot Syndrome, diagnosis and consequences Proefschrift ter verkrijging van het doctoraat in de Medische Wetenschappen aan de Rijksuniversiteit Groningen op gezag van de Rector Magnificus, dr. F. Zwarts, in het openbaar te verdedigen op woensdag 6 november 2002 om 16.00 uur doorJohannes Wilhelmus Gerardus Meijer geboren 21 januari 1966 te Hulst
  3. 3. Promotores Prof. drs. W.H. Eisma Prof. dr. J.W. GroothoffCo-promotores Dr. T.P. Links Dr. A.J. SmitBeoordelingscommissie Prof. dr. J.H. Arendzen Prof. dr. R.O.B. Gans Prof. dr. J.A. Lutterman
  4. 4. voor Miriamparanimfen H.R. Schiphorst Preuper F. de Laat
  5. 5. Correspondence Rehabilitation Centre Tolbrug Tolbrugstraat 11 PO Box 90153 5200 ME s-Hertogenbosch the Netherlands tel: +31-73-6992118/2128 fax: +31-73-6992895Printed by Ponsen & Looijen BV, Wageningen, the NetherlandsCover drawings Christiaan en Roeland MeijerThe publication of this thesis is financially supported by:Novo Nordisk Farma BV, OIM Groep, Diabetes Fonds,Vereniging Beatrixoord Haren, Coloplast BV, LIVIT Orthopedie,Basko Health Care BV, Maatschap Revalidatiegeneeskunde Den BoschMeijer, Jan-Willem G.The diabetic foot syndrome, diagnosis and consequences.Thesis University of Groningen, the Netherlands – With ref. – With summary inDutch.ISBN-number 90-77113-06-1© 2002: J.W.G. Meijer, Vlijmen, the Netherlands.All rights reserved. No parts of this publication may be printed or utilized in anyform by any electronic, mechanical or other means, now known or hereafterinvented, including photocopying and recording, or in any information storage orretrieval system, without written permission of the copyright holder.
  6. 6. ContentsChapter 1 Introduction and outline of the thesis 1Chapter 2 Evaluation of a screening and prevention programme for diabetic foot complications 11Chapter 3 Quality of life in patients with diabetic foot ulcers 23Chapter 4 Symptom scoring systems to diagnose distal polyneuropathy in diabetes: the Diabetic Neuropathy Symptom score 35Chapter 5 Diabetic Neuropathy Examination: a hierarchical scoring system to diagnose distal polyneuropathy in diabetes 51Chapter 6 Clinical diagnosis of diabetic polyneuropathy with the DNS and DNE score 63Chapter 7 Early polyneuropathy in diabetes: concurrent sensory and motor disturbances 77Chapter 8 Dissociation in polyneuropathy and cardiovascular autonomic neuropathy in diabetes mellitus 91Chapter 9 Discussion and conclusions 107Summary 127Samenvatting 133Northern Centre for Healthcare Research (NCH)and previous dissertations 139Dankwoord 145Curriculum Vitae 151
  7. 7. Chapter 1Introduction and outline of the thesis
  8. 8. 2 - The diabetic foot syndrome
  9. 9. 1.1 IntroductionA very disabling long-term complication of diabetes mellitus (DM) is thediabetic foot syndrome. The diabetic foot syndrome can be defined as anarray of foot abnormalities, resulting from peripheral neuropathy, macro-angiopathy and other consequences of metabolic disturbances 1. Thesedifferent causal factors may be present alone, but mostly occur incombination in patients with DM. Neuropathy, particularly symmetric distalpolyneuropathy, is the major etiological factor, and is present in 85% of thepatients with a diabetic foot problem 2. A clinical important manifestation ofthe diabetic foot syndrome is the diabetic foot ulcer, sometimes followed byamputation.In 2000, worldwide 157 million people are suffering from DM, of whichabout 20 million in Europe 3. In 1994 the prevalence of DM in theNetherlands among men and women of 20 years and older was estimated tobe 33.4/1000, and 42.5/1000, respectively, leading to 442.300 people withDM 4. About 50% of these people are undiagnosed 4. Type 2 DM is mostfrequent, with a presence of 80-90%, type 1 DM is present in 10-20% of thepopulation 4. As a sequence of demographic changes of the Dutch society, asthere are growth of the population and changes in age and sex distribution,the prevalence of DM will increase with 35-45% during the period 1994-2015 5. This increase will be even higher due to the development of moreadequate case finding/screening techniques and the tendency of increasingincidence rates in certain population subgroups 5.An ulcer will affect 15-25% of all individuals with diabetes at least once intheir lifetime, with an annual incidence of 2 - 3% 6,7. A cross-sectional studyin 4 general practitioner practices in the Netherlands showed that theprevalence of an infected foot lesion or ulcer in patients with diabetes was3% 8. An other study showed that 5% had an ulcer or had undergone anamputation 9. Thus, diabetic foot problems are common in our society.The relative risk of diabetes related lower extremity amputation has beenreported to vary between 10 (United Kingdom) and 40 (USA) 10,11. Theincidence of amputation in the Northern part of the Netherlands has beenstudied by van Houtum et al. and Rommers et al. Van Houtum found an age-adjusted incidence rate of 8/100.000 in the non-diabetic population and345/100.000 in the diabetic population in the province of Groningen in 1991-1992, with a relative risk for patients with DM of 45 12. The percentage ofamputations due to diabetes was 62%. For the entire Dutch population, theage adjusted incidence in the non-diabetic population was 12/100.000, for thediabetic population 250/100.000, with a relative risk of 20 12. The percentageof amputations due to diabetes was 47%. Rommers et al. found an incidence Chapter 1: Introduction and outline - 3
  10. 10. rate of amputations of 18-20/100.000 in the northern region of theNetherlands 13. This rate was rather constant from 1982-1994 and showed nosharp decrease in frequency despite new techniques such as used inintervention radiology and in vascular surgery. Unfortunately, thecontribution of diabetes is not known in these data.Apelqvist et al. showed that the recurrence of foot ulcers after 1, 3 and 5years of observation was 34%, 61% and 70% in diabetic patients withprevious foot ulcers, respectively. The long-term survival after amputationwas 80%, 59%, and 27% after 1, 3 and 5 years of observation. In patientswith primary healed ulcers, without the need of amputation, this was 92%,73% and 58%, respectively14. Once amputated, 30-50% of the patientsundergo amputation of the contralateral leg within 3 years 15.This leads to a major burden both on the patient and the health care system.The risk of amputation is a life long threat to the diabetic patient, and thecosts due to diabetic ulcers and amputation are high. In 1989, 3790 patientswere hospitalised due to diabetic foot ulcer in the Netherlands, costs ofhospital stay only already were estimated 45 million euro16. In 1992, 1810amputations were performed in diabetic patients, the medical costs wereestimated 20 million euro, costs of absenteeism and rehabilitation were nottaken into account 17. Ragnarson-Tennvall and Apelqvist studied the cost-effectiveness of the management of diabetic foot ulcers 18. Althoughmethodological aspects caused difficulties in comparing results betweencountries and settings, they state that treatment alternatives in which the limbis saved are more effective according long-term economic and quality of lifeaspects.Frequent assessment of risk factors is necessary for early detection of patientsat risk, followed by strict diabetes regulation, patient education about footcare and appropriate footwear 1. These measures can reduce or even preventamputations for diabetic foot disease 19. Bakker et al. evaluated theeffectiveness of a Dutch diabetic foot clinic 20. Co-ordinated screening,prevention and multidisciplinary treatment at this specialised clinic resultedin a decrease in number and duration of hospital admissions due to footulcers. Furthermore, a reduction was found in amputations of 43% 20.Edmonds et al. achieved healing in 86% of neuropathic ulcers and 72% ofischaemic ulcers, and a reduction of 50% of amputations, with a specialisedfoot clinic21.This is also the goal of the St. Vincent declaration 1989: a reduction of 50%of amputation in diabetic patients.The high number of amputations in patients with DM in the Northern part ofthe Netherlands, more specific in the province of Groningen, illustrated that4 - The diabetic foot syndrome
  11. 11. there was an urgent need to evaluate the care for the diabetic foot in thatregion. In the early nineties, no specific screening and preventionprogrammes existed, and foot complications were treated by variousspecialists, without multidisciplinary attunement.At the University Hospital Groningen, the care for diabetic foot disordersbecame more organised after starting a study in 1993. In this study, theDepartments of Rehabilitation Medicine, Internal Medicine andEndocrinology were collaborating. This resulted in this thesis and in amultidisciplinary approach of the diabetic foot in the University Hospital.This present study focuses on the extent of the problem of the diabetic footsyndrome, the consequences of the diabetic foot syndrome on quality of life,the development of tests to diagnose diabetic neuropathy, and the relationbetween neuropathy and angiopathy in diabetes. Chapter 1: Introduction and outline - 5
  12. 12. 6 - The diabetic foot syndrome
  13. 13. 1.2 Aims of the study and outline of the thesisThis study was performed at the diabetes outpatient clinic of the Departmentof Endocrinology of the University Hospital Groningen, and at theDepartment of Diabetes and Vascular Diseases of the Rehabilitation CentreBeatrixoord, to investigate the following questions:1 How many patients from the diabetes outpatient clinic of a UniversityHospital, unknown with diabetic foot complications, are at risk to developthese complications and what is their actual state of prevention?In chapter 2 the current diabetic foot screening and prevention programme ofthe diabetes outpatient clinic of the University Hospital Groningen has beenevaluated. Therefore, 50 patients with diabetes mellitus, unknown with footcomplications, were selected at random to assess a risk-profile and thepreventional status. The aim was to get insight in the extent of the localpopulation at risk and to form a basis for further development andorganisation of diabetic foot care at our hospital and rehabilitation centre.2 What is the influence of having a present or former foot ulcer on the qualityof life of patients with diabetes mellitus?In chapter 3 quality of life was measured in a group of diabetic patients withpresent or former foot ulcers and compared with diabetic patients unknownwith foot complications. Quality of life was studied on the domains physical,social and psychological functioning. Special attention was paid to mobilityand physical disabilities because of expected limitations on these items.3 Is it possible to modify the Neuropathy Symptom Score (NSS) and theNeurological Disability Score (NDS) into valid, easily managed, graded andaccurate scoring systems for diagnosing distal symmetric polyneuropathy indiabetes mellitus?Neuropathy, especially distal symmetric polyneuropathy, is a majoretiological factor in diabetic foot complications; in 85% of the diabeticpatients with ulcers neuropathy is present. Because of the lack of a goldstandard to diagnose neuropathy, the San Antonio Consensus Statement of1988 recommended to perform at least one measurement of 5 differentdiagnostic categories, including a symptom score and a physical examination Chapter 1: Introduction and outline - 7
  14. 14. score. Several scores are used, the Neuropathy Symptom Score (NSS) andthe Neurological Disability Score (NDS) are the most accepted scores. Bothare scores for neuropathy in general and not specific for distal symmetricpolyneuropathy. The aim of this study was to adapt the NSS and NDS intovalid, easily managed, graded and accurate scoring systems for diagnosingdistal symmetric polyneuropathy. These studies are described in chapter 4, 5and 6, respectively.4 Is polyneuropathy present in patients with DM before any sign of micro- ormacroangiopathy is detectable? Does sensory polyneuropathy occur prior tomotor neuropathy or do they occur simultaneously?In the pathogenesis of diabetic neuropathy a vascular and a metabolichypothesis exist. In this study, presence of sensory and motor polyneuropathywas evaluated in diabetic patients without micro- or macroangiopathy.In distal symmetric polyneuropathy, sensory dysfunction seems to run aheadof motor dysfunction, because of compensating mechanisms, such ascollateral innervation and muscle fiber hypertrophy. Invasive muscle fiberconduction velocity (I-MFCV) offers sensitive information about musclefiber volume and conduction velocity, and thus of early denervation. Inchapter 7, I-MFCV was used as an indicator for early motor dysfunction indiabetic patients.5 Do cardiovascular autonomic neuropathy tests reflect diabeticpolyneuropathy or diabetic vasculopathy?The frequently used Ewing Battery is known to have a high predictive valuein the development of diabetic foot complications. The San AntonioConsensus Statement recommends cardiovascular autonomic neuropathy(CAN) tests, as one of the five different categories for diagnosing diabeticneuropathy. However, evidence exists that the association with otherdiagnostic categories for neuropathy is weak, and that CAN is more stronglyrelated to vasculopathy in diabetes mellitus. Recently, new methods havebeen developed to measure CAN, such as Heart Rate Variability (HRV) andBaroreflex Sensitivity (BRS). In chapter 8 these tests for cardiovasculardysfunction were studied, and compared with conventional tests for distalsymmetric polyneuropathy and vascular examination.8 - The diabetic foot syndrome
  15. 15. 1.3 References1 Syllabus Richtlijnen diabetische retinopathie, diabetische nefropathie, diabetische voet en hart en vaatziekten bij diabetes mellitus. Richtlijnen NDF/CBO september 1998. Banda Heerenveen BV, the Netherlands.2 Boulton AJM. The pathogenesis of diabetic foot problems: an overview. Diabet Med 1996; 13: 12-16.3 Post D, Tuinstra J, Groothoff JW. Zorgconsumptie van patiënten met diabetes mellitus. Tijdschrift voor Gezondheidswetenschappen 2000; 78 (6): 354-60.4 Volksgezondheid Toekomst Verkenning 1997, I De gezondheidstoestand: een actualisering.5 Volksgezondheid Toekomst Verkenning 1997, De som der delen.6 Palumbo PJ, Melton LJ. Peripheral vascular diseases and diabetes. In: Harris MI, Hamman RF, eds. Diabetes in America. NIH publication No. 85-1468. Washington: US Government Printing Office, 1985: XV 1-21.7 Most R, Sinnock P. The epidemiology of lower extremity amputations in diabetic individuals. Diabetes Care 1983; 6: 87-91.8 Crebolder HFJM. De huisarts en de diabetische voet. In: Consensus bijeenkomst diabetische voet. Utrecht: CBO, 1985: 2-11.9 Verhoeven S, Ballegooije E van, Casparie AT. Impact of late complications in type II diabetes in a dutch population. Diabet Med 1991; 8: 435-8.10 Gujral JS, McNally PG, OMalley BP, Burden AC. Ethnic differences in the incidence of lower extremity amputation secondary to diabetes mellitus. Diabet Med 1993; 10: 271-74.11 Connel FA, Shaw C, Will J. Lower extremity amputations among persons with diabetes mellitus. Washington, 1988. MMWR 1991; 40: 737-39.12 Houtum van WH, Lavery LA. Regional variation in the incidence of diabetes-related amputations in the Netherlands. Diabetes Res and Clin Practice 1996; 31: 125-32.13 Rommers GM, Vos LDW, Groothoff JW, Eisma WH. Epidemiology of lower limb amputees in the north of the Netherlands: Aetiology, discharge destination and prosthetic use. Prosthetics and Orthotics International 1997; 21: 92-99.14 Apelqvist J, Larsson J, Agardh CD. Long-term prognosis for diabetic patients with foot ulcers. J of Internal Medicine 1993; 233: 485-91. Chapter 1: Introduction and outline - 9
  16. 16. 15 Bild DE, Selby JV, Sinnock P, Browner WS, Braveman P, Showstack JA. Lower-extremity amputation in people with diabetes. Epidemiology and prevention. Diabetes Care 1989; 12: 24-31.16 Bouter KP, Storm AJ, Groot RR de, Uitslager R, Erkelens DW, Diepersloot RJA. The diabetic foot in Dutch hospitals: epidiological features and clinical outcome. Eur J Med 1993; 2(4): 215-18.17 Houtum van WH, Lavery LA, Harkless LB. The cost of diabetes- related lower extremity amputations in the Netherlands. Diabet Med 1995; 12: 777-781.18 Ragnarson-Tennvall G, Apelqvist J. Cost-effective management of diabetic foot ulcers, a review. Pharmaco-economics 1997; 12 (1): 42- 53.19 Assal JP, Muhlhauser I, Pernat A, Gfeller R, Jorgens V, Berger M. Patient education as the basis for diabetic care in clinical practice. Diabetologia 1985; 28: 602-13.20 Bakker K, Dooren J. Een gespecialiseerde voetenpolikliniek voor diabetespatienten vermindert het aantal amputaties en is kostenbesparend. NTvG 1994; 138(11): 565-69.21 Edmonds ME, Blundell MP, Morris ME, Thomas EM, Cotton LT. Improved survival of the diabetic foot: the role of a specialized clinic. Q J Med 1986; 60 (232): 763-71.10 - The diabetic foot syndrome
  17. 17. Chapter 2 Evaluation of a screening and prevention programme for diabetic foot complications J.W.G. Meijer, T.P. Links, A.J. Smit, J.W. Groothoff, W.H. Eisma Prosthetics and Orthotics International 2001; 25: 132-38.© 2001 by ISPO; reprinted with their kind permission
  18. 18. AbstractIntroduction Foot complications in diabetes can be decreased by preventive measures. The current diabetic foot screening and prevention programme of the diabetes outpatient clinic of a university hospital was evaluated, by assessing the presence of risk factors for the development of foot disorders and the preventive measures taken.Methods 50 diabetic patients not known to have foot complications were selected at random. Risk factors and preventive measures were inventarised with the Coleman risk- categorisation system and the Preventive Measures Scale, respectively.Results 60% of the patients were at risk of developing diabetic foot complications. The preventive measures were low in these patients. Patient knowledge was insufficient and behaviour even worse. Basal preventive shoe adaptations were absent in most patients at risk. No relation between risk category and the preventional status was found.Discussion Cross-sectional examination at a university outpatient clinic showed serious risk profiles for foot complications, which were not balanced by the application of generally accepted preventive measures. At the outpatient clinic, screening should be optimised.12 - The diabetic foot syndrome
  19. 19. 2.1 IntroductionFoot complications have an enormous impact on the quality of life of patientswith diabetes mellitus and the financial cost is considerable 1,2. Frequentassessment of risk factors (neuropathy, foot deformity, history of ulcerationand angiopathy) is necessary for the early detection of patients at risk fordeveloping foot disease and for preventing amputation. Better patienteducation about foot care and appropriate footwear are expected to prevent atleast half of the amputations for diabetic foot disease 3-7.At the time of this study, standardised diabetes patient education with theusual attention to diabetic foot care was being given at the universityoutpatient clinic. This individual education is repeated every two years andthe feet are examined once a year or more frequently on indication.The aim of this study was to evaluate the clinics current screening andprevention programme by assessing the risk profile and the actual state ofprevention in a sample of patients, not known to have diabetic footcomplications, at the outpatient clinic. The information was intended to forma basis for further development and organisation of diabetic foot care at thehospital and rehabilitation centre.2.2 Patients and MethodsPatientsAt the diabetes outpatient clinic of the University Hospital Groningen, 55patients who had been suffering from diabetes mellitus for at least one year,but did not have any documented foot complications, were selected atrandom. Exclusion criteria were: causes of neuropathy other than diabetesmellitus, other neurological diseases or peripheral nerve disorders, high dosebenzodiazepine or analgesic use, cognitive or psychological problems as faras they might interfere with the test results, the presence or a history of footulceration and foot amputation.Five patients refused to take part in this research project.MethodsThe same specialist (JWGM) examined all 50 patients. In the same session,risk factors and preventive measures were assessed using a risk-categorisation system and the Preventive Measure Scale, respectively.Patients were not informed about the results of the tests. Chapter 2: Evaluation of screening and prevention - 13
  20. 20. 1 Colemans risk categorisationNo generally accepted risk profile is available to determine a patients risk ofdeveloping foot problems. The American Diabetes Association (ADA)recommends assessment of the four major risk factors: neuropathy, footdeformity, ulceration and angiopathy 8.As risk profile, Colemans risk-categorisation system was chosen 9, whichcovers these major risk factors. Four different risk categories are used (seeTable 1). In risk category 0 the only risk factor present is foot deformity. Incategory 1 neuropathy is present. In category 2 the presence of neuropathy iscombined with foot deformity, while in category 3 angiopathy or an ulcer arepresent.Table 1: Risk profile according to Coleman 9risk category 0 1 2 3Neuropathy - + + +Foot deformity -/+ - + +Ulceration and/or vascular laboratory - - - +findings implying angiopathyNumber of patients (%) 20 10 4 16 (40%) (20%) (8%) (32%)1a NeuropathyAccording to the recommendations of the ADA, the presence of neuropathywas determined with Semmes Weinstein Monofilaments (SWMF) and theVibration Perception Threshold (VPT) 10. These are semi-quantitative,reliable instruments, complementary to each other, with proven predictivevalue for the development of clinical problems, such as foot ulcers and theneed for amputation 11-18. Both were applied 6 times to two locations on bothfeet. Insensitivity to the 10 gram SWMF was scored as absence of protectivesensibility. The VPT was determined with a hand-held biothesiometer(Biomedical Instruments Inc., Ohio, USA) and compared to the referencevalues published by Young et al.17. Neuropathy was defined as a disturbedVPT and/or insensitivity to the 10-gram SWMF at one location or more.1b Foot deformityFoot deformity was defined as comprising at least one of the followingobvious deformities: claw toes, overlying toes, prominent bony parts andhallux rigidus or valgus.14 - The diabetic foot syndrome
  21. 21. 1c UlcerationPatients with ulceration or a history of ulceration were excluded from thisstudy.1d AngiopathyIn Colemans system, angiopathy is defined as vascular laboratory findingsindicating significant angiopathy. Ankle/brachial indexes at the arteriadorsalis pedis and arteria tibialis posterior and toe/brachial indexes at thehallux on both sides using laser-doppler flowmetry, were measured.Ankle/brachial indexes of below 0.90 and toe/brachial indexes of below 0.75were considered abnormal 19. Angiopathy was diagnosed if one or moreabnormal value was observed.2 The Preventive Measures ScaleAccording to recommendations of the American Diabetes Association,diabetic patients should be educated regarding their risk factors andappropriate management 10. Assessment of a persons current knowledge andcare practices should be obtained. Patients should understand the implicationsof the loss of protective sensation, the importance of foot monitoring on adaily basis, the proper care of the foot, including nail and skin care, and theselection of appropriate footwear. It is known that the type of evidence for theeffectiveness of these specific interventions varies, ranging from evidencebased (randomised controlled trials) for prescription of adequate footwear toexpert or consensus opinions of the other interventions.In literature there is no valid score available to quantify the preventive statusof these patients. Therefore, a panel of medical specialists of the UniversityHospital, all members of the Diabetic Foot working group, developed thePMS on expert and consensus opinion regarding the recommendations of theADA, several education programmes, guidelines for shoes, and theliterature9,10,20-22.The PMS has four sub-scales: (1) patient knowledge (7 items), (2) carepractice (9 items), (3) condition of feet and shoes (10 items) and (4)prevention by health care workers (5 items). Sub-scales 1, 2 and 4 are basedon self-reporting, 3 is based on observation. The PMS is standardised, self-reporting questions could be answered yes or no. Observation criteria for sub-scale 3 were described in detail before starting the study. Adequate measuresreceived 0 points, inadequate measures received 1 point, thus the maximumscore was 31 points. The PMS is shown in Appendix 1. Chapter 2: Evaluation of screening and prevention - 15
  22. 22. StatisticsThe statistical package SPSS-PC was used for all the analyses, includingcomputation of the descriptive statistics, Spearmans Correlation Coefficientand Oneway Multiple Range Test.2.3 ResultsCharacteristics of the 50 participants are shown in Table 2. The mean agewas 51.4 years (min 18, max 89 yrs), while the mean duration of DM was14.1 years (min 1, max 36 yrs). The group consisted of 32 men and 18women; 22 had type 1 DM and 28 had type 2 DM.Table 2: Patient characteristicsN 50mean age (years) (SD) 51.4 (16.2)min – max (years) 18 – 89mean duration diabetes (years) (SD) 14.1 (9.1)min – max (years) 1 – 36sexmale : female 32:18type of diabetestype 1 : type 2 22 : 28mean HbA1c (%) (SD) 8.6 (1.4)min – max 6.6 - 13.51 Colemans risk categorisation60% of the patients had scores that placed them in risk categories 1-3. Thesepatients were at risk. 40% scored in category 0, which means the lowest risk,because there were no risk factors (or only the presence of foot deformitywithout any other risk factors) (Table 1).2 Preventive measuresTable 3 presents the mean scores on the sub-scales of the PreventiveMeasures Scale for each risk category. A large percentage of the patientswere not taking any preventive measures in any of the four sub-scales. Foot-16 - The diabetic foot syndrome
  23. 23. care behaviour and foot-care knowledge were inadequate. The scores forfoot-care behaviour were even worse than those for foot-care knowledge.Basal preventive demands of shoes, such as fitting, presence of seamlessinsides and pressure distributing inlays, were absent in most patients at risk,in 53% (16/30), 67% (20/30) and 70% (21/30), respectively.No relation was found between the risk category and the preventive measuresscale (Spearmans correlation coefficient 0.24). There were no significantdifferences in the scores on the preventive measures scale between the fourrisk categories.Table 3: Preventive Measures ScaleThe mean percentage of patients in each category who were not performingthe preventive measurerisk category 0 1 2 3number of patients 20 10 4 161 Patient Knowledge: 39.2 40.0 37.5 46.02 Patient Care Practice: 56.7 47.8 56.1 52.03 Condition of Feet and Shoes: 56.8 55.2 40.1 63.34 Preventive Measures by Health Workers: 68.0 50.0 50.0 61.22.4 DiscussionUsing Colemans risk-categorisation system, 60 per cent of the study groupwere found to be at serious risk of developing diabetic foot complications,despite the availability of a screening and education programme. The samplewas recruited at a university hospital outpatient clinic and did not have anydocumented foot disorders. Foot-care knowledge and foot-care behaviourwere inadequate. The scores for preventive foot-care behaviour were worsethan those for foot-care knowledge; there was no relation between the sub-scale prevention and risk category. Protective measures by shoe adaptationswere insufficient. This means that the screening and prevention programme,even though it follows generally prescribed procedures, is inadequate and thatpatients do not comply sufficiently with preventive self-care. This might be Chapter 2: Evaluation of screening and prevention - 17
  24. 24. exacerbated by the fact that doctors and patients are inclined to underestimatefoot care. In both doctors and patients thresholds need to be overcome inexamining the feet. In doctors, time is scarce and foot inspection takes time.Many patients have visual problems, which complicate inspection, and somehave cosmetic objections towards wearing orthopaedic footwear.The study group was not fully representative of the entire population at theoutpatient clinic, because of the exclusion criteria used. The study group wasyounger, did not have any documented foot problems, had a shorter durationof diabetes mellitus and there were relatively more male patients. Theobjection might be raised that the study sample was small and, because it wasuniversity-hospital-based, it was not representative. However, the percentageat risk was so high that valid conclusions can be drawn about the need forpreventive care, even in this small sample. Similar risk estimates for thegeneral population will underestimate the situation, because patients with (ahistory of) foot ulcers were excluded and because everyone had receivedstandardised diabetes patient education.Several validated tests to diagnose and evaluate neuropathy are available indifferent diagnostic categories, such as symptom scoring, physicalexamination, quantitative sensory testing, electrodiagnostic studies andautonomic function testing. According to a consensus statement one test fromeach of these five diagnostic categories has to be used to diagnose andevaluate neuropathy 23. In clinical practice, certainly at an outpatient clinic,this is not feasible for screening purposes. The ADA recently recommendedthe use of psychophysical somatosensory threshold tests (especially VPT byBiothesiometry and SWMF testing) because these tests provide the bestdiscrimination in the clinical setting to identify the loss of sensation 10. Bothrecommended tests have been used in this study. However, there is still nocombination of tests available with the optimal predictive value to diabeticfoot ulcer. By using only these two methods still cases will be missed duringscreening, so the percentage at risk will even be higher than 60%.It is questionable whether the highest risk category should be defined by thepresence of angiopathy. Several studies have shown that neuropathy played alarger role in the development of ulceration and the need for amputation thanangiopathy 7,20,24-26. This means that for the entire 60% (categories 1-3:neuropathy present) the risk is high and preventive foot care is of greatimportance.Because there was no score available in literature, the Preventive MeasuresScale was developed to standardise the quantification of the preventivemeasures being taken by patients. Validation of the PMS was beyond the18 - The diabetic foot syndrome
  25. 25. scope of this study. The PMS is not broad enough to evaluate educationprogrammes, because information about the social system, coping, behaviourand health locus of control are lacking. However, the PMS does provide asimple, standardised instrument to assess the preventive measures beingtaken by patients. Three sub-scales are based on self-report. Patients mightrespond socially desirable, which means that the real situation of preventionis even worse than reported.In view of the findings of this evaluation, the screening and preventionprogramme has to be revised. Because our programme closely followsgenerally accepted programmes, this need for revision will hold for manyinstitutions. In our opinion, the screening programme needs to be adapted tofollow the advice of the 1998 Dutch consensus on diabetic foot disease 27,which means more intense examination of the presence of risk factors.Naturally, to be of any benefit, early diagnosis of patients at risk will have tobe followed by preventive measures and regular check-ups. For this purpose,a multidisciplinary diabetic foot team and intensive education programmeshave been started at the University Hospital and rehabilitation centre. Theeducation programme offers information and individual or group traininggiven by a multidisciplinary rehabilitation team. The major goal of thisprogramme is to increase the level of preventive self-care.Physicians, podiatrists and shoe-technicians need to be aware that they willhave to provide adequate footwear to an enormous number of patients at risk.Furthermore they should underpin their work, specifically the indications andeffects of adaptations and their preventive value.Using a simple risk-categorisation system combined with improvedprevention strategies for patients at risk of developing diabetic foot problems,we are attempting to balance the presence of risk factors and the applicationof preventive measures. It is clear that patients, health care workers andhealth insurance companies will have to invest a great deal of time andmoney in foot care to reach the goal of the St. Vincent Declaration, i.e. a 50%reduction in major amputations. Chapter 2: Evaluation of screening and prevention - 19
  26. 26. 2.5 References1 Bakker K, Dooren J. Een gespecialiseerde voetenpolikliniek voor diabetespatiënten vermindert het aantal amputaties en is kostenbesparend. NTvG 1994; 11: 565-69.2 Ollendorf DA, Kotsanos JG, Wishner WJ. Potential economic benefits of lower-extremity amputation prevention strategies in diabetes. Diabetes Care 1998; 21:1240-45.3 Assal JP, Muhlhouser I, Pernet A, Gfeller R, Jorgens V, Berger M. Patient education as the basis for diabetic foot care in clinical practice. Diabetologia 1985; 28: 602-613.4 Edmonds ME, Blundell MP, Morris ME, Maelor TE, Thomas E, Cotton LT, Watkins PJ. Improved survival of the diabetic foot: the role of the specialised foot clinic. Quart J of Med 1986; 232: 763-71.5 Schaff PS, Cavanagh PR. Shoes for the insensitive foot: the effect of a "rocker bottom" shoe modification of plantar pressure distribution. Foot Ankle 1990; 11: 129-40.6 Barth R, Campbell LV, Allen S, Jupp JJ, Chisholm DJ. Intensive education improves knowledge, compliance and foot problems in type 2 diabetes. Diabet Med 1991; 8: 111-17.7 Thomson FJ, Veves A, Ashe H, Knowles EA, Gem J, Walker MG. A team approach to diabetic foot care: the Manchester experience. The Foot 1991; 2: 75-82.8 American Diabetes Association. Preventive foot care in people with diabetes. Diabetes Care 2000; 23: s55-56.9 Coleman WC. Footwear in a management program for injury prevention. In: Levin ME, ONeal LW, Bowker JH (eds). The Diabetic Foot, 5th edition. St. Louis: Mosby-Year Book, 1993, P 533-36.10 Mayfield JA, Reiber GE, Sanders LJ, Janisse D, Pogach LM. Preventive foot care in people with diabetes. Diabetes Care 1998; 21: 2161-77.11 Goldberg JM, Lindblom U. Standardised method of determining vibratory perception thresholds for diagnosis and screening in neurological investigation. J of Neur, Neurosurg and Psych 1979; 42: 793-803.12 Bloom S, Till S, Sonksen P, Smith S. Use of a biothesiometer to measure individual vibration thresholds and their variation in 519 non- diabetic subjects. BMJ 1984; 288: 1793-95.13 Birke JA, Sims DS. Plantar sensory threshold in the ulcerative foot. Lepr Rev 1986; 57: 261-67.14 Sosenko JM, Kato M, Soto R, BiId DE. Comparison of quantitative sensory-threshold measures for their association with foot ulceration in diabetic patients. Diabetes Care 1990; 13: 1057-61.20 - The diabetic foot syndrome
  27. 27. 15 Kumar S, Fernando DJS, Veves A, Knowles EA, Young MJ, Boulton AJM. Semmes Weinstein Monofilaments: a simple, effective and inex- pensive screening device for identifying diabetic patients at risk of foot ulceration. Diab Res and Clin Pract 1991; 13: 63-68.16 Veves A, Uccioli L, Manes C, van Acker K, Komninou H, Philippides P, Katsilambros N, de Leeuw I, Menzinger G, Boulton AJM. Comparison of risk factors for foot problems in diabetic patients attending hospital outpatient clinics in four different European States. Diabet Med 1994; 11: 709-11.17 Young MJ, Breddy L, Veves A, Boulton AJM. The prediction of diabetic neuropathic foot ulceration using vibratory perception thresholds. Diabetes Care 1994; 17: 557-60.18 Valk GD, De Sonnaville JJJ, van Houtum WH. The assessment of diabetic polyneuropathy in daily clinical practice. Muscle and Nerve 1997; 20: 116-18.19 Conier SA. Role of pressure measurements. In: Bernstein EF (ed). Vascular Diagnosis, 4th edition. St. Louis: Mosby, 1993, p 486-512.20 Boulton AJM. Peripheral neuropathy and the diabetic foot. The Foot 1992; 2: 67-72.21 Edmonds ME, Foster AVM. Diabetic Foot Clinic. In: Levin ME, ONeal LW, Bowker JH (eds). The Diabetic Foot, 5th edition. St. Louis: Mosby-Year Book, 1993, p 599-603.22 Caputo GM, Cavanagh PR, Ulbrecht JS, Gibbons GW, Karchmer AW. Assessment and management of foot disease in patients with diabetes. N Engl J Med 1994; 331: 854-860.23 American Diabetes Association, American Academy of Neurology. Report and recommendations of the San Antonio Conference on Diabetic neuropathy (Consensus Statement). Diabetes Care 1988; 11: 592-97.24 Boulton AJM, Kubrusly DB, Bowker JH, Gadia MT, Quintero L, Becker DM, Skyler JS, Sosenko JM. Impaired vibratory perception and diabetic foot ulceration. Diabet Med 1986; 3: 335-37.25 Pecaro RE, Reiber GE, Burgess EM. Causal pathways to amputation: basis for prevention. Diabetes Care 1990; 13: 513-21.26 Boulton AJM. The pathogenesis of diabetic foot problems: an overview. Diabet Med 1996; 13: 12-16.27 CBO/NDF. Diabetische retinopathie, diabetische nefropathie, diabetische voet, hart en vaatziekten bij diabetes mellitus. Heerenveen, the Netherlands: Banda, 1998. Chapter 2: Evaluation of screening and prevention - 21
  28. 28. Appendix 1: Preventive Measures Scale1: Patient Foot-care Knowledge: 7 itemsDo you know about the necessity of:taking special foot care due to diabetes?daily inspection of the feet to control for presence of ulcers?daily washing of the feet?not walking barefoot?adequate fitting of the shoes?visit the doctor for wound care?special shoe demands?2: Patient Foot-care Practice: 9 itemsDo you pay special attention to:care of the feet?daily washing of the feet?the use of oil for the skin?examine the feet for wounds daily?the use of a mirror for inspection?foot inspection by others?not to walk barefoot?inspection of the shoes?wearing seamless stockings?3: Condition of feet and shoes: 10 itemsObservation criteria: scored as:condition of nails inadequate: fungal infections, inadequate trimming, ingrown nailscondition of skin inadequate: dry crackled skin, maceration, callus, tinea pedisstockings adequate: seamlessfitting of stockings inadequate: pinch off effectsinside of shoes adequate: seamlessfitting of shoes adequate: widest part at MTP-I, length longest toe to shoe 1.5-2 cm, sufficient room at toesshoe counter adequate: fixation of heel and foot, no slippingsole adequate: rigid protecting against penetration traumadistributing inlay adequate: distribution of pressure over entire plantar surfacerocker bottom adequate: right place, decreasing pressure plantar forefoot4: Preventive Measures by Health Care Workers: 5 itemsDo your health care workers offer:foot care (by general practitioner)?foot care (by endocrinologist)?prescription for special shoes?urgent visit for wounds?annual foot inspection?22 - The diabetic foot syndrome
  29. 29. Chapter 3 Quality of life in patients with diabetic foot ulcers J.W.G. Meijer, J. Trip, S.M.H.J. Jaegers, T.P. Links, A.J. Smit, J.W. Groothoff, W.H. Eisma Disability and Rehabilitation 2001; 23 (8): 336-340.© 2001 by Taylor and Francis; reprinted with their kind permission
  30. 30. AbstractAim To compare Quality of Life (QoL) between diabetic patients with (former or present) and without foot ulcers.Methods Two patient groups of comparable age, sex distribution, type distribution and duration of diabetes were studied. Fourteen patients with former or present, but clinically stable diabetic foot ulcers (DFUs) were examined. The control group were 24 patients not known to have DFUs. None of the participants had other diabetic complications or conditions that would potentially affect QoL. A diabetic foot risk score and QoL were assessed. QoL was scored with the RAND-36, the Barthel Score (ADL) and the Walking and Walking Stairs Questionnaire (WSQ).Results Marked and significant differences were found in physical functioning (p<.001), social functioning (p<.05), physical role (p<.001) and health experience (p<.05) between the two groups with the RAND-36 and the four sub-scales of the WSQ (all p<.001). On all these scales, QoL was significantly poorer in the study group. A correlation was found between the risk score and QoL (physical functioning and physical role Spearmans r: -.66, -.56 and WSQ -.63, -.64, -.67 and -.71, respectively).Discussion Presence or history of DFUs has a large impact on physical role, physical functioning and mobility. Physical impairments especially influenced QoL. Probably, QoL can be increased by providing attention that will enhance mobility and by giving advice about adaptations and special equipment.24 - The diabetic foot syndrome
  31. 31. 3.1 IntroductionA disabling long-term complication of diabetes mellitus (DM) is the diabeticfoot ulcer (DFU), caused by the presence of neuropathy, angiopathy and/orfoot deformity 1. DFUs are common and it is estimated that they affect 15%of all individuals with DM during their lifetime 2.Recently, three studies have been published on Quality of Life (QoL) inpatients with DFUs. Rijken et al. 3 studied the association of foot pain withseveral other parameters in the field of impairments, disabilities and qualityof life in 29 patients, without controls. There were no patients with ulcersincluded. Several clinical variables and four unvalidated functional variableswere assessed on fatigue, functional ability, walking distance and quality oflife. In this study foot pain was related to fatigue, disability in walking and alower level of quality of life.Carrington et al. 4 examined 13 diabetic patients with ulcers, 13 diabeticpatients with a unilateral amputation and 26 controls. They assessedpsychological adjustment to illness (PAIS), anxiety and depression (HAD)and life satisfaction (QoL ladder) and concluded that the psychological statusof mobile amputees is better than that of the diabetic foot ulcer patients, butnot as good as diabetic controls. They did not assess mobility.Brod 5 studied quality of life in diabetic patients with foot ulcers and theircaregivers, by semi-structured discussions on the domains of social,psychological, physical and economic impact. Two groups participated,consisting of 14 patients and 11 caregivers without a control group. Anegative impact on all domains of QoL was experienced because of thelimitations in mobility caused by the ulcer. The conclusions were groupfindings and not based on individual assessments.In conclusion, QoL in diabetic patients with foot ulcers is greatly influencedby physical (especially mobility), social and psychological impairments anddisabilities. However, it is not clear which specific domains of QoL are mostaffected by DFUs.The aim of this study was to evaluate the QoL of individual patients withpresent or former DFUs by comparing them to DM patients not known tohave DFUs. QoL was defined as "the physical, social and psychologicalfunctioning of the patients as being influenced by disease or therapy", andwas investigated using the sub-items mobility, activities of daily living andgeneral QoL 6-8. Chapter 3: Quality of life - 25
  32. 32. 3.2 Patients and MethodsPatientsA cross-sectional patient-control study was performed on patients who wereadmitted to the Diabetes Department of the Rehabilitation Centre Beatrixoordbetween 1993 and 1997. Two groups were composed, a study group withpatients with DM who had been hospitalised because of DFUs and a controlgroup with patients without any foot problems, who had a diabetes durationof at least 1 year and had been admitted because of diabetic dysregulation.Patients were included if they were ambulatory at the time of the study.Exclusion criteria were: not diabetes related diseases ( neurological ororthopaedic problems, cardiac or pulmonary problems), diabetes relatedproblems (severe retinopathy, nephropathy, amputation above the level of thetoes, unstable ulcers on the feet and symptomatic diabetic polyneuropathy)and cognitive or psychological problems.During the period studied, 410 patients had been admitted to the departmentfor various reasons (dysregulation, amputation, instruction and prevention,ulcers etc). To select patients and controls, the records were read by JT andchecked by JWGM. Referring to the in- and exclusion criteria mentioned, 31patients were initially selected for the study group and 53 for the controlgroup. To get informed about the actual state of the patients, their generalpractitioners were contacted to check in- and exclusion criteria just beforestarting the study. This led to the exclusion of 12 patients of the study groupand 20 of the control group, the reasons are described in Table 1.Unfortunately 5 patients of the study group and 9 of the controls refused totake part in the study, resulting in 14 participants of the study group and 24 ofthe control group, as shown in Table 1.Table 1: Patient selection Study group Control groupinitially selected 31 53 5 died 3 diedcheck general -12 5 comorbidity -20 15 comorbiditypractitioner 2 moved house 2 moved houseselected 19 33 -5 refused -9 refusedparticipated 14 2426 - The diabetic foot syndrome
  33. 33. MethodsRisk profiles for diabetic foot complications were determined and QoL wasassessed. The same observer examined all the patients (JT).1 Risk ProfileThe risk profile test from the Dutch consensus report on the diabetic foot wasused to assess the risk of developing foot complications 1. This profileemploys the known risk factors neuropathy, angiopathy, foot deformity andulceration. Risk is graded from 0 (no risk) to 3 (highest risk). In grade 0, noneof the 4 risk factors are present. In grade 1 the only risk factor present isneuropathy; in grade 2 neuropathy is present combined with angiopathy orfoot deformity, while in grade 3 there is an existing or previous ulcer 1.Neuropathy was diagnosed with Semmes Weinstein Monofilaments. Inabilityto feel the 10-gram filament at 4 plantar locations on the foot was defined asthe presence of neuropathy 9-11. Angiopathy was defined as symptomaticarterial disease (Fontaine class 2 or higher) and/or absence of arterial footpulsations. Foot deformity was defined as the presence of halluxvalgus/rigidus, prominent bony parts or pressure areas. Ulceration waspresent when there were Wagner stage 1 to 5 abnormalities 12.2 Quality of LifeQoL was assessed with the RAND-36, the Barthel Index and the Walkingand Walking Stairs Questionnaire (WSQ).2.1 RAND-36The RAND-36 is a general questionnaire for measuring the influence ofhealth on QoL (physical, psychological and social aspects) 13. It has proven tobe valid and reliable 13. There are 8 domains: physical and social functioning,emotional and physical impairment of role, mental health, vitality, pain andexperienced health. For each domain there is a minimum score of 0 and amaximum score of 100. The higher the score, the better the quality of life.2.2 Barthel IndexThe Barthel index is a questionnaire on skills/disabilities of activities of dailyliving (ADL), which consists of 10 questions ranging from bowel and bladdercontrol items to mobility and personal care items 14,15. The maximum score is20 points (normal); less than 10 points means severely impaired ADL.2.3 Walking and Walking Stairs QuestionnaireA reliable and valid preliminary version of the Walking and Walking StairsQuestionnaire (WSQ) was used to evaluate mobility 16,17. This questionnaireconsists of 62 items, divided into 4 hierarchical scales: using stairs (16 items), Chapter 3: Quality of life - 27
  34. 34. walking indoors (18 items), walking outdoors (20 items) and walkingvelocity (8 items). Each scale has a maximum of 100 points; the higher thescore, the better the mobility.StatisticsThe statistical package SPSS-PC was used to compute descriptive statistics,Spearmans correlation coefficient and the Mann Whitney test.Significance level: p < .05.Differences on item level were computed by calculating the Effect Size (EF)( t-tests for means), defined as 18:MeanA − MeanB SS A + SSB , where Sp = Sp (N A − 1) + (N B − 1)MeanA = mean of group A, MeanB = mean of group B, Sp = Pooled standard deviation,SSA = sum of squares of group A, SSB = sum of squares of group B, NA = total of group A,NB = total of group BInterpretation of the ES: no or trivial effect < 0.20; small effect = 0.20 – 0.49; mediumeffect = 0.50 – 0.79; large effect = > 0.79 19.3.3 ResultsPatient characteristics are shown in Table 2. The two groups were found to becomparable regarding age, sex distribution, known duration and type of DM(no significant differences).The patients selected initially for the study (n=31) and control (n=53) groupswere compared to the patients who actually participated in the two groups onthe items sex distribution, age, known duration and type of diabetes. In theparticipating control group, the mean duration of diabetes was significantlylonger than that in the excluded group. In the study group with foot ulcersthere were significantly more men than in the group of excluded patients. Noother significant differences were found between the subjects selectedinitially and those who actually participated.28 - The diabetic foot syndrome
  35. 35. Table 2: Patient characteristics study group control groupn 14 24Sex (male : female) 10 : 4 13 : 11Age (years) (mean (SD)) 62.8 (13.8) 58.7 (13.8)Duration DM (years) (mean (SD)) 11.3 (10.8) 12.8 (12.0)Type of DM (1 : 2) 3 : 11 10 : 141 Risk ProfileA significant difference was found in the risk profile between the two groups(p-value < .0001). The study group had a higher risk of developing footcomplications (mean score of 3.00; SD 0.0) than the control group (meanscore 0.58; SD 1.10).2 Quality of Life2.1 RAND-36Patients in the study group scored both relevantly and significantly lower(experienced a lower QoL) than the controls on the domains physicalfunctioning, social functioning, physical role and health experience, as shownin Table 3.On an item level, the most relevant and significant differences (Effect Size)were present for producing moderate (1.4) and heavy physical effort (1.8),walking distances of more than 500 metres (1.2) and using stairs (1.4). Thepatients also experienced problems with working, especially a lowerproductivity (1.1). There were no differences in complaints about pain. Chapter 3: Quality of life - 29
  36. 36. Table 3: RAND-36 study group control group mean ± SD mean ± SDPhysical functioning 52.1 ± 31.7 ** 90.0 ± 15.9Social functioning 80.4 ± 27.6 * 96.4 ± 7.8Physical role 42.9 ± 34.6 ** 83.3 ± 29.2Emotional role 92.3 ± 14.6 ns 84.7 ± 31.1Mental health 75.7 ± 19.5 ns 77.2 ± 15.6Vitality 71.2 ± 16.0 ns 72.3 ± 15.9Pain 68.7 ± 28.4 ns 76.2 ± 14.3Health experience 51.1 ± 23.1 * 66.4 ± 14.9* ** ns p < .05, p < .001, not significant2.2 Barthel IndexThe study group scored 19.2 points (SD 1.5), and the control group scored19.8 points (SD 0.5) (not significant).2.3 WSQIn all four categories, the study group had significantly lower scores than thecontrol group, which means that the patients with foot ulceration experiencedmore disabilities on mobility than the controls. The study group scored 80.0points for using stairs versus 96.7 points in the controls (p<.001); for walkingindoors the scores were 54.8 and 90.3 (p<.001), respectively. For walkingoutdoors, the study group scored 54.5 points versus 87.0 in the controls(p<.001), while for walking velocity, these scores were 51.8 and 89.1 points(p<.001) respectively.On the level of individual items, the most relevant and significant differences(Effect Size) between the two groups were observed for using stairs both upand down (more effort (1.4), more time (1.1)) and for walking small distancesin (1.1) and outdoors (1.5).30 - The diabetic foot syndrome
  37. 37. 3 Relation between Risk Profile and Quality of LifeIn Table 4 the significant correlations between risk profile and QoL areshown for the entire study population. The severity of the risk profile wassignificantly related to QoL on all the scales of the WSQ and on the physicalfunctioning and impairment of physical role domains of the RAND-36. Therewas no significant correlation between risk profile and social functioning,self-perceived health and the other domains of the RAND-36 or the BarthelIndex.Table 4: Relation between Risk Profile and Quality of Life (Spearmans r) RAND-36 Physical functioning -.66* Physical role -.56* WSQ Using stairs -.64* Walking indoors -.67* Walking outdoors -.71* Walking velocity -.63*Only the significant correlations are shown, * p < .0013.4 DiscussionThis study addressed the interrelations between physical, social andpsychological dimensions of QoL in DM patients. The obvious physicallimitations of patients with DFUs, reflected by the WSQ and by the physicalfunctioning domain of the RAND-36, greatly affected QoL, and wereprobably causing limitations in social functioning.On an individual level, there were highly relevant and significant differencesfor producing moderate and heavy physical effort, walking in and outdoors,using the stairs both up and down (more effort, more time) and working(lower production). In contrast with the results reported by Rijken3, we didnot find a relation between having a DFU and complaints of pain. Whereasother studies found more psychological complaints in patients with foot Chapter 3: Quality of life - 31
  38. 38. disease4, this was not found in our study for the item psychologicalfunctioning. Very few of our patients had an acute phase of foot disease.Perhaps they had learnt to accept their disabilities and had found a newpsychological balance.In conclusion, an existing or previous ulcer has an obvious negative influenceon the physical and social aspects of quality of life in patients with diabetesmellitus. This is in line with the findings of earlier studies 3,5.In a general population of patients with diabetes, psychological and socialaspects contributed to the overall QoL, while physical complaints had lessinfluence 20. This suggests that having a diabetic foot changes the spectrum offactors that influence QoL, with an increase in the impact of limitationsrelated to physical functioning and mobility.The population studied is not very large and selected at a specific institution.Therefore generalisation might be limited. However, the influence of physicaldisabilities on quality of life, by decreasing mobility of patients, is verysignificant and relevant for workers in the field of rehabilitation.Despite the fact that the clinical situation was stable in all the patients withDFUs at the time of the study, their mobility and physical functioning werelimited. The significant correlation between risk profile and QoL suggeststhat the decrease in physical functioning and mobility in the patients with footdisease was caused by physical restrictions due to the DFU itself, or due tosigns and symptoms of risk factors, such as neuropathy or angiopathy. Thisdecrease might have been further strengthened by restrictions imposed bypreventive patient education (for example patients are advised to walk onlyshort distances). Our data emphasize the necessity to pay attention to mobilityin patients with clinical stable foot ulcers.In conclusion, diabetic foot ulcers have a large impact on quality of life,especially on physical functioning, social functioning and mobility. Physicaldisabilities, due to the presence of risk factors or ulcers, are responsible forthis decrease in quality of life.In our opinion, combining diabetic foot prevention programmes with arehabilitation programme for patients with DFUs can increase quality of life.Such a programme might provide physical training for these patients (toenhance their condition and decrease disabilities), increase awareness aboutadaptations and equipment to enhance mobility (prescription of specialfootwear, walking aids or electric trikes and stair-lifts) and offer vocationaltherapy.This study was sponsored by a grant from the Vereniging Beatrixoord,Haren, the Netherlands32 - The diabetic foot syndrome
  39. 39. 3.5 References1 Centraal Begeleidingsorgaan voor de Intercollegiale Toetsing, Nederlandse Diabetes Federatie. Richtlijnen NDF/CBO de Diabetische Voet. Heerenveen:Banda, 1998.2 Palumbo PJ, Melton LJ. Peripheral vascular disease and diabetes. In: Harris MI, Hamman RF eds. Diabetes in America. NIH publ. No. 85- 1468. Washington: US Government Printing Office, 1985; XV: 1-21.3 Rijken PM, Dekker J, Dekker E et al. Clinical and functional correlates of foot pain in diabetic patients. Disability and Rehabilitation 1998; 20(9): 330-36.4 Carrington AL, Mawdsley SKV, Morley M, Kincey J, Boulton AJM. Psychological status of diabetic people with or without lower limb disability. Diabetes Research and Clinical Practice 1996; 32: 19-25.5 Brod M. Quality of life issues in patients with diabetes and lower extremity ulcers: patients and care givers. Quality of Life Research 1998; 7 (4): 365-72.6 Fitzpatrick R, Fletcher A, Gore S, Jones D, Spiegelhalter D, Cox D. Quality of life measures in health care: applications and issues in assessment. British Medical Journal 1992; 305: 1074.7 Revicki DA. Quality of life and non-insulin-dependent diabetes mellitus. Diabetes spectrum 1990; 3: 260.8 World Health Organisation. The first ten years of the World Health Organisation. Geneva: WHO, 1959: 459.9 Caputo JW, Cavanagh PR, Ulbrecht JS, Gibbons GW, Karchmer AW. Assessment and management of foot disease in patients with diabetes mellitus. New England Journal of Medicine 1994; 331: 854-60.10 Birke JA, Sims DS. Plantar sensory threshold in the ulcerative foot. Leprosy Review 1986; 57: 261-67.11 Uccioli L, Boulton AJM. Comparison of risk factors for foot problems in diabetic patients attending hospital outpatient clinics in four different European states. Diabet Med 1994; 11: 709-11.12 Wagner FW. The dysvascular foot: a system for diagnosis and treatment. Foot and Ankle 1981; 2: 64-122.13 Zee K van der, Sanderman R. Het meten van de algemene gezondheidstoestand met de RAND-36. Noordelijk Centrum voor Gezondheidsvraagstukken, Rijksuniversiteit Groningen, 1993: 1-28.14 Mahoney FI, Barthel DW. Functional evaluation: the Barthel Index. Md State Med J 1965; 14: 61-65.15 Wade DT, Collin C. The Barthel ADL Index: A standard measure of physical disability? International Disability Studies 1988; 10: 64-67. Chapter 3: Quality of life - 33
  40. 40. 16 Roorda LD, Roebroeck ME, Lankhorst GJ, Tilburg TG van. De vragenlijst loopvaardigheid: hierarchische schalen om beperkingen in het opstaan en lopen te meten. Revalidata 1996; 18: 34-8.17 Roorda LD, Roebroeck ME, Lankhorst GJ, Tilburg TG van. Measuring functional limitations in rising and sitting down: development of a questionnaire. Archives of Physical Medicine and Rehabilitation 1996; 77: 663-69.18 J.H.Zar , Biostatistical Analyses, 1999, New Jersey.19 J.Cohen, Statistical Power Analysis for the Behavioral Scienes, New York, 1969.20 Rose M, Burkert U, Scholler G, Schirop T, Danzer G, Klapp BF. Determinants of quality of life of patients with diabetes under intensified insulin therapy. Diabetes Care 1998; 21(11): 1876-85.34 - The diabetic foot syndrome
  41. 41. Chapter 4 Symptom scoring systems to diagnose distal polyneuropathy in diabetes: the Diabetic Neuropathy Symptom score J.W.G. Meijer, A.J. Smit, E. van Sonderen, J.W. Groothoff, W.H. Eisma, T.P. Links Diabetic Medicine, short version, in press.© 2002 by Blackwell Ltd and Diabetes UK;reprinted with their kind permission
  42. 42. AbstractAims Distal polyneuropathy (PNP) is the major risk factor for diabetic foot disease. One of its diagnostic categories is symptom scoring. Several scoring systems are available. The generally accepted Neuropathy Symptom Score (NSS) (17 items) is valid but extensive. We developed, on expert opinion, the 4 item Diabetic Neuropathy Symptom (DNS) score, very manageable but not yet validated. The aim of this study was to validate the DNS-score for diagnosing distal PNP in diabetes.Methods In 73 patients, the score characteristics of the NSS and the DNS-score were compared, and construct validity, predictive value and reproducibility were assessed with the Diabetic Neuropathy Examination score, Semmes Weinstein Monofilaments and Vibration Perception Threshold (clinical standards).Results 43 men and 30 women were studied (mean duration of diabetes 15 years (1-43), mean age 57 years (19-90)). Twenty-four patients had type 1 diabetes, and 49 type 2. Correlation between NSS and DNS-score was high (Spearman r = 0.88). Patients scored more differentiated on the DNS-score. The relation of the NSS and DNS- score, respectively, with the clinical standards was good (Spearman r = 0.21 - 0.60). Both scores had a comparable predictive value. Reproducibility of the DNS-score was good (Cohen weighted Kappa .78-.95). The DNS-score was easier to perform and therefore preferred above the NSS.Conclusions The DNS-score is a validated symptom score, fast and easy to perform in clinical practice, with high predictive value to screen for PNP in diabetes.36 - The diabetic foot syndrome
  43. 43. 4.1 IntroductionDistal symmetric polyneuropathy (PNP) is a very common complication ofdiabetes and is considered to be a major causal factor in the majority of footulcers in diabetic patients 1,2. To diagnose PNP, the San Antonio consensusreport advises that at least one measurement should be performed in 5different diagnostic categories 3. One of these categories is symptom scoring.In our opinion, the value of systematic assessment of symptoms is oftenmisunderstood in clinical practice, and is not based on standardised scoring ofa specific set of questions. Diagnosis is usually based on QuantitativeSensory Testing or Physical Examination. However, symptoms are importantto evaluate, because they reflect the complaints of the patient, they may be ofadditional diagnostic or prognostic value and treatment might be possible 4.As diagnostic tests, symptom scores should fulfil the criteria as described byJaeschke et al. 5. The scores have to be validated (presence of an independentreference standard, adequate spectrum and number of patients,standardisation, soundly based item selection), they should be of predictivevalue and manageable in clinical practice (reproducibility, performance inclinical practice) 5.Several scores have been developed to assess symptoms of diabeticneuropathy.The Neuropathy Symptom Score (NSS) 4, 6-8 and the Neuropathy SymptomProfile (NSP) 9 both assess diabetic neuropathy. The NSS is the most widelystudied and accepted score, and known to be valid and sensitive 4, 6-8. TheNeuropathy Symptom Profile contains 34 test categories. It is validated andcan be read and scored by computer 9. Because both scores assess neuropathyin general, they are rather extensive in clinical practice. The MichiganNeuropathy Screening Instrument (MNSI) 10 and the modified NSS scores ofVeves and Young 11,12 have been developed specifically for distal diabeticpolyneuropathy. The MNSI is a combination of a symptom score (15 items)and a physical examination score 10. The combination is valid and has a highpredictive value. However, there is no separate symptom score, as advised byconsensus reports 3. No information is available to review the modificationsof the NSS scores of Veves and Young 11,12. The Diabetes SymptomChecklist type 2 (DSC-type 2) 13 and the McGill Pain Questionnaire 14 arescores for diabetes in general and pain, respectively. The DSC-type 2 hasbeen validated both as an entire score and for neuropathy symptoms alone 13.Of the items concerning neuropathy, only numbness and tingling sensationsat both hand and feet were associated with other diagnostic standards fordiabetic neuropathy 15. The McGill Pain Questionnaire scores for painfuldiabetic leg problems 14, but no data is available about validity and predictivevalue. The Diabetic Neuropathy Symptom score (DNS-score), developed at Chapter 4: the DNS-score - 37
  44. 44. our hospital, consists of 4 items chosen on clinical relevance and experience,as the most typical and clinically relevant for distal symmetric PNP indiabetes. This score has not been validated or published before.Because none of these scoring systems fulfil Jaeschkes criteria for diagnostictests 5, the aim of this study was to validate the DNS-score for diagnosingdistal symmetric PNP in diabetes, and to compare its score-characteristicswith the NSS.4.2 Patients and MethodsPatients:Our study group consisted of 73 patients with diabetes, covering the entirespectrum of secondary complications. Informed consent was obtained fromall participating patients. Exclusion criteria were factors that may interferewith the neurological condition of the subjects other than PNP.Fifty of these 73 patients were randomly selected from the diabetes outpatientclinic of the University Hospital Groningen. The other 23 patients, all knownwith obvious diabetic foot complications or clinical neuropathy, wereselected from the Department of Diabetes at the Rehabilitation Centre Beat-rixoord.The characteristics of the 73 patients are shown in Table 1.Table 1: Patient Characteristics N 73 Mean age (years)(SD) 56.9 (16.1) Min – max (years) 19 – 90 Mean duration DM (years) (SD) 14.9 (9.9) Min – max (years) 1 – 43 Sex Male – female 43 – 30 Type DM 1- 2 24 – 49 Mean HbA1c (%) (SD) 8.7 (1.4) Min – max 6.6 – 13.5 Retinopathy 40% Nephropathy 42% Peripheral vascular disease 38% Present or former ulcer 20%38 - The diabetic foot syndrome
  45. 45. Methods:The same researcher (J.-W.G.M.) examined all 73 patients. First, thesymptom scores were performed followed by clinical standards; a physicalexamination score ( the Diabetic Neuropathy Examination (DNE) score) andquantitative sensory tests (Semmes Weinstein Monofilaments and vibrationperception thresholds), respectively.1 Symptom Scores1.1 NSSThe NSS consists of 17 items, 8 focusing on muscle weakness, 5 on sensorydisturbances and 4 on autonomic symptoms 4,6. Items that are answerednegative/absent are scored 0, presence scored as 1 point. Maximum score ofthe NSS is 17 points 4, 6-8.1.2 DNS-scoreAn expert panel of the University Hospital (Groningen, the Netherlands)developed a 4 item symptom score for diabetic PNP. The panel consisted of adiabetologist/endocrinologist, a specialist for internal vascular diseases, aneurologist and a physician for rehabilitation medicine; all experienced indiagnosing diabetic neuropathy. The DNS-score consists of the followingitems: (1) unsteadiness in walking, (2) pain, burning or aching at legs or feet,(3) prickling sensations at legs or feet, and (4) numbness at legs or feet.Presence is scored as 1 point, absence as 0 points, maximum score 4 points.Guidelines to use with the score are shown in Appendix 1.2 Clinical StandardsThe Diabetic Neuropathy Examination (DNE) score, Semmes-WeinsteinMonofilaments (SWMF) and Vibration Perception Threshold (VPT) werechosen as clinical standards to study the construct validity of the symptomscoring systems for PNP.2.1 DNE-scoreThe DNE-score is a validated, hierarchical physical examination score todiagnose distal symmetric PNP in diabetes 16. It exists of 8 items; 2 itemstesting muscle strength, 1 item testing a tendon reflex and 5 items testingsensation. The maximum score is 16 points. A score of > 3 points is definedas disturbed/abnormal.2.2 Semmes-Weinstein Monofilaments (SWMF)SWMFs were tested on the plantar surface of the hallux and central at theheel (when necessary after removal of excessive callus). This method wasperformed standardised according to generally accepted guidelines 17-20. The Chapter 4: the DNS-score - 39
  46. 46. "yes-no" method was used. This means that the patient says yes each timethat he or she senses the application of a monofilament. Six trials were taken,when the patient was unable to respond correct in more than 1 trial, a heaviermonofilament was taken. The 1, 10 and 75 gram monofilaments have beenused 17-20. This resulted in four categories: category 1: 1 gram monofilamentfelt; category 2: 10 gram felt, 1 gram not felt; category 3: 75 gram felt, 10gram not felt; category 4: 75 gram not felt. In categories 1 and 2 sensitivity ispresent, therefore they are scored as normal. Categories 3 and 4 are scored asabnormal.2.3 Vibration Perception Threshold (VPT)VPTs were determined using a hand-held biothesiometer (Biomedical Instru-ments Inc., Ohio, USA). VPT was tested at the dorsum of the hallux on theinterphalangeal joint and at the lateral malleolus. It was performed in astandardised way 21-23. The voltage of vibration was increased until the patientcould perceive a vibration. This was done three times. The mean of thesethree was used to determine the VPT. Age-adjusted reference values wereused 21-23. Values higher than the mean+2*SD (reference value) wereconsidered as abnormal.ReproducibilityIn order to test reproducibility of the DNS-score, inter- and intrarateragreement were assessed in a separate study on 10 patients. The 6 womenand 4 men, with a mean age of 50.0 years (SD15.9) had a wide range ofneuropathy severity. The mean duration of DM was 11.5 years (SD 10.5); 3participants had type 1 DM and 7 had type 2 DM. Two doctors, anendocrinologist and a physician for rehabilitation medicine, both experiencedin diagnosing diabetic neuropathies, rated these patients twice with aninterval of one week.Statistical AnalysesInternal consistency of the symptom scores was assessed by calculatingCronbachs alpha, and reliability coefficient Rho, which is comparable toalpha. The statistical package SPSS-PC was used to compute the descriptivestatistics, reliability coefficient Crohnbach’s alpha, Spearmans correlationcoefficient r, Students t-test and ROC curves 24. Inter- and intrarateragreement was assessed using Cohen’s weighted Kappa 25,26.40 - The diabetic foot syndrome
  47. 47. 4.3 ResultsIn Table 2 general information about the NSS and the DNS-score is shown.The reliability of the DNS-score seems to be a little lower than of the NSS.This is, however, due to the considerable reduction of items, and not to alower association between the items. Correlation (Spearman r) between thesetwo symptom scores is, as expected, high: .88.Table 2: Characteristics of the symptom scores. NSS DNS-score Mean (SD) 1.9 (2.0) 1.1 (1.3) Reliability (alpha) .74 .64 Number of items 17 4 Maximum score 10 4 Non used items 4 0Relationship of the NSS and DNS-score with the Clinical StandardsSpearmans correlation coefficient r for the DNE-score with the NSS andDNS-score was similar with values of .56 and .60 (both p<.001),respectively. Spearmans correlation coefficient r for the SWMF with theNSS and DNS-score was .21 (not significant) and .25 (p<.05), respectively.For VPT, Spearmans correlation coefficient r with the NSS and DNS-scorewas .46 and .56 (both p<.001), respectively.The NSS and the DNS-score predicted the results of the clinical standardsadequately, as shown in Table 3. Chapter 4: the DNS-score - 41
  48. 48. Table 3 Relation Clinical Standards - Symptom Scoresgroup 0= normal on clinical standard, group 1= disturbed on clinical standardDNE-score: N mean NSS (SD) mean DNS (SD) 0 24 .92 (1.47) .42 (.93) 1 48 2.42 (2.07) 1.52 (1.24) p .002 p .000Semmes Weinstein Monofilaments Hallux: N mean NSS (SD) mean DNS (SD) 0 45 1.42 (1.42) .84 (1.04) 1 25 2.64 (2.63) 1.56 (1.41) p .014 p .019Vibration Perception Threshold Hallux: N mean NSS (SD) mean DNS (SD) 0 39 1.28 (1.47) .67 (.98) 1 32 2.63 (2.34) 1.69 (1.30) p .004 p .000Sensitivity / SpecificityFigure 1 shows the ROC-curves of, respectively, the NSS and DNS-score ascompared with the DNE-score. For NSS and DNS-score the areas under thecurve are .75 and .78, respectively. Using the SWMF at the hallux thesevalues are .62 and .65, respectively; and using VPT .68 and .73, respectively.At a cut off point of 0 versus 1-4 for the DNS-score, sensitivity was 79% andspecificity 78% regarding the DNE-score. Regarding SWMF sensitivity was81% and specificity 56%, for VPT sensitivity was 81% and specificity 58%.42 - The diabetic foot syndrome
  49. 49. Figure 1: ROC-curves of NSS and DNS-score, respectively, in relation to theDNE-score. 1,00 ,75 ,50 sensitivity ,25 Referenc e Li DNS -score 0,00 NSS 0,00 ,25 ,50 ,75 1,00 1-specificityReproducibility of the DNS-scoreThe intrarater agreement showed Cohen’s weighted Kappa’s for both ratersof .89 and .78, the interrater agreement on two occasions was .95, and .83,respectively, indicating a good to very good level of agreement 25,26. Chapter 4: the DNS-score - 43
  50. 50. 4.4 DiscussionThe NSS is a validated and widely accepted symptom score for diabeticneuropathy 4, 6-8. The most frequent form of neuropathy in diabetes and majorrisk factor for diabetic foot disease is distal symmetric PNP 1. Several itemsof the NSS are seldom scored, because the NSS has not been developedspecifically for distal PNP. Large groups of diabetic patients need to bescreened regularly to diagnose PNP early as part of prevention of diabeticfoot ulcers. Consequently, several other scoring systems and modificationshave been developed, but they do not sufficiently fulfil all the criterianecessary for adequate diagnostic tests. In this study, the DNS-score wasvalidated with the aim of achieving a manageable symptom scoring systemfor diagnosing distal symmetric diabetic PNP in clinical practice andepidemiological studies.We compared the score-characteristics of the DNS-score with the originalNSS. Furthermore, the construct validity of the NSS and DNS-score has beenstudied by comparing the scores with the clinical standards chosen: the DNE-score, SWMF and VPT. We conclude that both symptom scores adequatelyfulfil the criteria for diagnostic tests, as mentioned in the introduction. Weprefer the DNS-score for further use as symptom score, because thedifferences between the scores on validity and predictive value are small andnot clinically relevant, and the manageability of the DNS-score is excellent.Consisting of only 4 items, the DNS-score is fast and easy to perform inclinical practice with a high reproducibility.Diagnostic tests can be discriminative (diagnosis), predictive (prognosis) orevaluative (follow up). The DNS-score is validated with clinical standards ondiscriminative and predictive values. For evaluation of treatment or followup, the score might be too short with only four items. However, in the NSSthe number of items related to PNP is also very limited.Unfortunately the exact weight of the different categories, individual or incombination, in diagnosing diabetic PNP and predicting diabetic footcomplications, is not yet known.Sensitivity and specificity of the DNS-score were high regarding the DNEscore, SWMF and VPT. Because the DNS-score will be used for screeningpurposes, sensitivity is preferred above specificity. A score of 1 or morepoints on the DNS-score is very sensitive for presence of diabetic PNP. Incombination with the results of the other diagnostic categories of the SanAntonio Consensus, this gives an indication of type and severity of PNP.44 - The diabetic foot syndrome
  51. 51. Controversy exists about the use of symptom scoring in diagnosing PNP indiabetes. Because symptoms of neuropathy (pain, numbness and tingling) arepresent in 30-40% of all people with diabetes, Mayfield et al. concluded thatthe presence or absence of symptoms should not be used to assess the risk ofulcers or amputation 27. Valk et al. found that symptoms of neuropathic painand paraesthesia were neither correlated with the results of physicalexamination nor with the results of neurophysiological examination 15. Inanother study they concluded that only symptoms of numbness and tinglingsensations in hand and feet (items of the DSC-type 2), were associated withthe clinical examination, but not with neurophysiological examination 28.Franse et al. studied whether a patient history could replace the ClinicalNeurological Examination (CNE). The individual symptoms wereinsufficiently predictive for the presence of polyneuropathy. They concludedthat individual symptoms could not replace the CNE 29. Dyck et al. found anassociation between complaints of diabetic neuropathy, abnormalities of theclinical examination and abnormalities of nerve conduction 7. In our reportsignificant and clinically relevant correlations have been shown between thesymptom scores and the DNE-score, SWMF and VPT, respectively; whichare all accepted tests with known predictive value for diabetic footcomplications. Therefore, as the consensus advises, we state that symptomscoring deserves to be a part of the diagnostic set, complementary to otherdiagnostic categories for diabetic PNP 3.It is known that the reliability of symptom scores may be poorer than thereliability of the other diagnostic categories 3,4,8. This might be caused by thesubjectivity of the scores, leading to a poor reproducibility. The consensusadvises to score dichotomous to enhance reliability 3. In the DNS-score, ashort and dichotomous symptom score, the reproducibility is high.In conclusion, the DNS-score, a symptom score specific for distal symmetricPNP in diabetes, has now been validated, and is fast and easy to perform inclinical practice. As the consensus advises, this scale has to be usedcomplementary to other diagnostic categories as for example standardisedphysical examination (for example the DNE-score) and quantitative sensorytesting. Further prospective studies are necessary with the DNS-score, theDNE-score and other diagnostic tests, to assess the predictive value of thescales and items. Chapter 4: the DNS-score - 45
  52. 52. 4.5 References1 Boulton AJM. The pathogenesis of diabetic foot problems: an overview. Diabet Med 1996; 13: s12-s16.2 Caputo GM, Cavanagh PR, Ulbrecht JS, Gibbons GW, Karchmer AW. Assessment and management of foot disease in patients with diabetes. N Engl J Med 1994; 331: 854-860.3 Consensus Statement: Report and recommendations of the San Anto- nio conference on diabetic neuropathy. Diabetes Care 1988; 11: 592- 97.4 Dyck PJ. Detection, characterization and staging of polyneuropathy: assessed in diabetics. Muscle and Nerve 1988; 11: 21-32.5 Jaeschke R, Guyatt G, Sacket DL. Users guides to the medical literature: how to use an article about a diagnostic test. JAMA 1994; 271: 389-391.6 Dyck PJ, Sherman WR, Hallcher LM Service FJ, OBrien PC, Grina LA, Palumbo PJ, Swanson CJ. Human diabetic endoneurial sorbitol, fructose and myo-inositol related to sural nerve morphometry. Annals of Neurology 1980; 6: 590-96.7 Dyck PJ, Karnes JL, Daube J, OBrien P, Service JF. Clinical and neuropathological criteria for the diagnosis and staging of diabetic polyneuropathy. Brain 1985; 108: 861-80.8 Dyck PJ, Kratz KM, Lehman KA, Karnes JL, Melton LJ, OBrien PC, Litchy WJ, Windebank AJ, Smith BE, Low PA, Service FJ, Rizza RA, Zimmerman BR. The Rochester diabetic neuropathy study: design, criteria for types of neuropathy, selection bias, and reproducibility of neuropathic tests. Neurology 1991; 41: 799-807.9 Dyck PJ, Karnes J, OBrien PC, Swanson CJ. Neuropathy Symptom Profile in health, motor neuron disease, diabetic neuropathy, and amyloidosis. Neurology 1986; 36: 1300-08.10 Feldman EL, Stevens MJ, Thomas PK, Brown MB, Canal N, Greene DA. Practical two-step quantitative clinical and electrophysiological assessment for the diagnosis and staging of diabetic neuropathy. Diabetes Care 1994; 17: 1281-89.11 Veves A, Manes C, Murray HJ, Young MJ, Boulton AJM. Painful neuropathy and foot ulceration in diabetic patients. Diabetes Care 1993; 16: 1187-89.12 Young MJ, Boulton AJM, Macleod AF, Williams DRR, Sonksen PH. A multicentre study of the prevalence of diabetic peripheral neuropathy in the United Kingdom hospital clinic population. Diabetologia 1993; 36: 150-54.46 - The diabetic foot syndrome
  53. 53. 13 Grootenhuis PA, Snoek FJ, Heine RJ, Bouter LM. Development of a type 2 diabetes symptom checklist: a measure of symptom severity. Diabet Med 1994; 11: 253-61.14 Masson EA, Hunt L, Gem JM, Boulton AJM. A novel approach to the diagnosis and assessment of symptomatic diabetic neuropathy. Pain 1989; 38: 25-28.15 Valk GD, Grootenhuis PA, Bouter LM, Bertelsmann FW. Complaints of neuropathy related to the clinical and neurophysiological assessment of nerve function in patients with diabetes mellitus. Diab Res and Clin Pract 1994; 26: 29-34.16 Meijer JWG, van Sonderen E, Blaauwwiekel EE, Smit AJ, Groothoff JW, Eisma WH, Links TP. Diabetic neuropathy Examination: a hierarchical scoring system to diagnose distal polyneuropathy in diabetes. Diabetes Care 2000; 23: 750-53.17 Birke JA, Sims DS. Plantar sensory threshold in the ulcerative foot. Leprosy Review 1986; 57: 261-67.18 Kumar S, Fernando DJS, Veves A, Knowles EA, Young MJ, Boulton AJM. Semmes Weinstein Monofilaments: a simple, effective and inex- pensive screening device for identifying diabetic patients at risk of foot ulceration. Diab Res and Clin Pract 1991; 13: 63-68.19 Mueller MJ. Identifying patients with diabetes mellitus who are at risk for lower extremity complications: use of Semmes Weinstein monofilaments. Physical Therapy 1996; 76: 68-71.20 Armstrong DG, Lavery LA, Vela SA, Quebedeaux TL, Fleischli JG. Choosing a practical screening instrument to identify patients at risk for diabetic foot ulceration. Archives of Internal Medicine 1998; 158: 289-92.21 Goldberg JM, Lindblom U. Standardised method of determining vibratory perception thresholds for diagnosis and screening in neurological investigation. J of Neur, Neurosurg and Psych 1979; 42: 793-803.22 Bloom S, Till S, Sonksen P, Smith S. Use of a biothesiometer to measure individual vibration thresholds and their variation in 519 non- diabetic subjects. BMJ 1984; 288: 1793-95.23 Young MJ, Breddy L, Veves A, Boulton AJM. The prediction of diabetic neuropathic foot ulceration using vibratory perception thresholds. Diabetes Care 1994; 17: 557-60.24 Hanley JA, McNeil BJ. A method of comparing the areas under the receiver operating characteristic curves derived from the same cases. Radiology 1983; 148: 839-43.25 Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics 1977; 33: 159-74. Chapter 4: the DNS-score - 47
  54. 54. 26 Altman DG, ed. Practical statistics for medical research. London: Chapman and Hall, 1997.27 Mayfield JA, Reiber GE, Sanders LJ, Janisse D, Pogach LM. Preventive foot care in people with diabetes. Diabetes Care 1998; 21: 2161-77.28 Valk GD, Nauta JJP, Strijers RLM, Bertelsman FW. Clinical examination versus neurophysiological examination in the diagnosis of diabetic polyneuropathy. Diabet Med 1992; 9: 716-21.29 Franse LV, Valk GD, Dekker JH, Heine RJ, van Eijk JTM. Numbness of the feet is a poor indicator for polyneuropathy in type 2 diabetic patients. Diabet Med 2000; 17: 105-10.48 - The diabetic foot syndrome
  55. 55. Appendix 1: DNS-score DNS-score and guidelines 1 Are you suffering of unsteadiness in walking? need for visual control, increase in the dark, walk like a drunk man, lack of contact with floor remark: it is assumed that the patient has no limiting visual, hearing or central neurological deficits. 2 Do you have a burning, aching pain or tenderness at your legs or feet? remark: it is assumed that intermittent claudication has been made unlikely by excluding pain which develops during walking and disappears upon halting, and that ischaemic rest pain is made unlikely by lack of effect of dependency, in both cases further supported by the lack of absent foot-ankle pulsation and/or reduced ankle- and toe pressures. 3 Do you have prickling sensations at your legs and feet? occurring at rest or at night, distal>proximal, stocking glove distribution 4 Do you have places of numbness on your legs or feet? Distal>proximal, stocking glove distributionThe questions should be answered "yes" (positive: 1 point) if a symptom occurred moretimes a week during the last 2 weeks or "no" (negative: no point) if it did not.Max. score: 4 points0 points: PNP absent1-4 points: PNP present Chapter 4: the DNS-score - 49
  56. 56. 50 - The diabetic foot syndrome
  57. 57. Chapter 5 Diabetic Neuropathy Examination: a hierarchical scoring system to diagnose distal polyneuropathy in diabetes J.W.G. Meijer, E. van Sonderen, E.E. Blaauwwiekel, A.J. Smit, J.W. Groothoff, W.H. Eisma, T.P. Links Diabetes Care 2000; 23 (6): 750-753.© 2000 by the American Diabetes Association;reprinted with their kind permission
  58. 58. AbstractObjective Existing physical examination scoring systems for distal diabetic polyneuropathy (PNP) do not fulfil all of the following criteria: validity, manageability, predictive value, and hierarchy. The aim of this study was to adapt the Neuropathy Disability Score (NDS) to diagnose PNP in diabetes mellitus (DM) so that it fulfils these criteria.Methods A total of 73 patients with DM were examined with the NDS. Monofilaments and biothesiometry were used as clinical standards for PNP to modify the NDS.Results A total of 43 men and 30 women were studied; the mean duration of DM was 15 years (1-43), and the mean age was 57 years (19-90). Twenty-four patients had DM type 1 and 49 had type 2 DM. Clinically relevant items were selected from the original 35 NDS items (specific item scored positive score in > 3 patients). The resulting 8-item Diabetic Neuropathy Examination score (DNE) could accurately predict the results of the clinical standards and is strongly hierarchical (H-value 0.53). The sensitivity and specificity of the DNE at a cut-off level of 3 to 4 were 0.96 and 0.51 for abnormal monofilament scores, respectively. For abnormal biothesiometry scores, these values were 0.97 and 0.59, respectively. Reproducibility, as assessed by inter- and intrarater agreement, was good.Conclusions The DNE is a sensitive and well-validated hierarchic scoring system that is fast and easy to perform in clinical practice.52 - The diabetic foot syndrome