Clinical Guidelines for Type 2 Diabetes

Transcription

1 Clinical Guidelines for Type 2 Diabetes Prevention management of foot problems Revised version The prevention management of foot problems 103

2 13. Appendices (This file contains Appendices Appendices the full guideline are available as separate files) 104 Clinical Guidelines for Type 2 Diabetes

3 Appendix 1: Monitoring Author(s) Study Type of intervention Setting Inclusion criteria/ Exclusion criteria Mean age±sd (years) Male/female ratio 58±12 (20-83) Follow-up Pham H. et al 2000 Prospective T1: Neuropathy symptom score (based on presence/ absence of symptoms) T2: Neuropathy disability score (based on physical examination) T3: Vibration perception threshold, using biothesiometer vibrating at 100Hz, applied voltage 0-50V. Mean of 3 readings on each foot, on pulp of toe T4: Semmes-Weinstein monofilaments, 8 used applying pressure from 1-100g to evaluate cutaneous perception threshold on plantar aspect of hallux. T5: maximal plantar foot pressure, mean of 3 mid-gait footsteps 3 diabetic foot centres, Texas, USA None N=248 Inclusion: diabetes, Type 1 or Type 2, diagnosis Exclusion: none stated M126: F125 Type 1 49: Type Caucasian 119: Black 36: Hispanic months mean (range 6-40) development of foot ulceration independent predictors of foot ulceration Foot ulcers developed in 95 (19%) feet or 73 (29%) of patients. 22 (9%) developed ulcers in both feet. No difference in age between those who developed ulcers those who did not, but ulcer developers more likely to be men (with ulcers M49, F 24, without ulcers M75, F100, p<0.0001) had diabetes for longer (with ulcers, 16±12 years, without ulcers 13±10, p=0.019). Multivariate logistic regression: risk of ulceration associated with high T1, T2, T3 T4 (all p<0.0001). Sensitivity Specificity Positive predictive value T2 high score ( 5) T3, high voltage ( 25V) T4: high ( 5.07) T5: high pressure ( 6kg/cm 2 ) T1: high /or T T1: high /or T T3: high /or T Clinical examination (neuropathic disability score) has highest sensitivity for predicting risk of foot ulceration. The combination of high neuropathic score high Semmes Weinstein monofilament cutaneous perception. Foot pressure measurements have high specificity could be used as a postscreening test. The prevention management of foot problems 105

4 Appendix 1 (contd): Monitoring Author(s) Study Type of intervention Setting Pacaud D et al, 1999 Observational Questionnaire, demographic, general health, diabetes associated health Bilateral foot examination vibration perception threshold to assess neuropathy (using age based norms of manufacturer) Semmes-Weinstein monofilaments test for neuropathy University hospital outpatient diabetes clinic, Montreal, Canada None N=160 Inclusion: Inclusion: Type 1 or Type 2 attending follow-up visit to endocrinologist in diabetes clinic Exclusion: none stated Mean age±sd (years) 56.7±1.2 M77, F83 T1 46: T2 113, 1 unknown Type 1: 46 Type 2: 113 Follow-up None Sensitivity specificity of monofilament technique, using vibration perception threshold as the gold stard Moderate to severe neuropathy was present in 56.4% of group, using the vibration perception thresholds (Type %, Type % p<0.05). Monofilament technique had 97% sensitivity 89% specificity, against the vibration perception threshold as the gold stard. Presence of symptoms was a poor indicator or neuropathy. 44% of subjects without symptoms had neuropathy. 40% had never had feet examined, 60.3% of these had neuropathy compared with 53.3% of those who had had their feet examined (p>0.05). Monofilament testing is a good screening tool for presence of neuropathy. Clinical decisions to examine feet based on duration of diabetes presence of symptoms was inappropriate. 106 Clinical Guidelines for Type 2 Diabetes

5 Appendix 1 (contd): Monitoring Author(s) Study Type of intervention Setting Paisley AN et al, 2002 Observational Nerve function using Neuropathy Disability Score Vibration perception threshold on tip of hallux, both feet, mean of 3 readings Neuropen comprises monofilament 10g for cutaneous pressure assessment a sterile Neurotip for assessing pain sensation. Diabetes Centre or high risk diabetic foot clinic, Mancheste r, UK None N=124 Inclusion: Type 1 or Type 2 Exclusion: nondiabetic neuropathy. Mean age±sd (years) 55.4±13.7 M84, F40 T1 34, T2 80 Follow-up None Sensitivity specificity of Neuropen to assess peripheral nerve function using neuropathy Disability Score vibration perception thresholds as gold stards. Sensitivity specificity of the Neuropen to identify patients with moderate to severe neuropathy compared with abnormal cut-off values. Specificity of the Neuropen was improved when a combination of both abnormal monofilament abnormal Neurotip were used rather than the individual tests Neuropathy Disability Score (>6/10): Monofilaments sensitivity 87.8% specificity 57.3% Neurotip 91.8% 41.3% Neuropen (either monofilaments or Neurotip abnormal) 98% 30.7% Neuropen (both monofilaments Neurotip abnormal) 81.6% 68% Vibration perception threshold (>25V): Monofilaments 90.7% 63.8% Neurotip 87% 39% Neuropen (either monofilaments or Neurotip abnormal) 96.3% 31.9% Neuropen (both monofilaments Neurotip abnormal) 81.5% 71% The Neuropen could be used to identify patients with moderate to severe neuropathy, who are therefore at risk of foot ulceration. The prevention management of foot problems 107

6 Appendix 1 (contd): Monitoring Author (s) Mayfiel d JA et al, 2000 Study Type of intervention Setting Case control Case: had nontraumatic amputation of lower extremity, between Jan 85 Dec 92. Control: no lower-limb amputation by Dec 92 Primary care, Arizona, USA None Cases: 61 Controls: controls to each case Inclusion: diabetes (Type 2), lived in specific reservation districts, Pima or Tohono O odham Indian, aged 25-85, taking part in another longitudinal diabetes study Mean age±sd (years) Cases: 56.2±11.0 Controls: 47.7±11.4 Cases: M53%, F 47% Controls: M37%, F63% Cases were all Type 2, not stated if controls were. Followup 36 months, retrospecti ve Pivotal event leading to amputation Health care use in 36 months before amputation Foot examination, type of examination Health conditions diabetes complications Significant differences between cases controls for age, sex, duration of diabetes, prior foot ulcer, foot deformity. After adjusting for differences in demographics, foot risk conditions, disease severity, preventive foot examinations in Pima Indians gave a non-significant reduced risk of lower-extremity amputation, OR=0.55, 95% CI 0.17, 1.7, p=0.31. Non-adherence with foot care recommendations or medication produced a non-significant increased risk of amputation, OR=1.9, 95% CI 0.88, 4.3, p=0.1. Foot examinations do not decrease the risk of amputation in Pima Indians with Type 2 diabetes 108 Clinical Guidelines for Type 2 Diabetes

7 Appendix 2: Organisation of care: trials (selected endpoints) Trial Porter, 1982 Hayes et al, 1984 Hoskins et al, 1993 Treatment Comparison(s) Other features HOS: Continuing hospital diabetes clinic GP: General practitioner care Regular meetings were held between hospital staff general practice doctors other professionals before during the study. A special record form was provided for use by GPs. An administrative system for recalling patients was provided for practices that did not have one. HOS: Continuing hospital diabetes clinic GP: General practitioner care GP patients were given information leaflets, special record cards, were advised to be seen every 6 months. GPs had open access to hospital laboratory, dietetic chiropody services, freedom to refer back to the clinic HOS: Hospital diabetes clinic GP: General practitioner care SC: Shared care between GP clinic All patients received a multi-disciplinary assessment at baseline received an individualised treatment plan. GP/SC clinicians were sent patient management plans, asked to complete 4 monthly reviews refer patients to clinic for annual assessment SC group patients were sent their own copy of management plan. SC group received research nurse liaison who reminded patients GPs of content of reviews prompted GPs for the return of test results. Location East Fife, Scotl Cardiff, Wales (urban/rural mix) Sydney, Australia (urban) Baseline comparability Not reported Yes, except HOS: more abnormal ECGs Yes, except GP: greater proportion of females at p>0.05 Blinding level None None None Concealment Not reported Yes (independently prepared, Yes (lottery system, numbers drawn from a of al Inclusion/ exclusion Length of follow-up Loss to follow-up (%) Type of analysis Outcomes/ endpoints Economic data Included: NIDDM patients. sealed envelopes) Included: Stabilised Type II diabetes patients, age 40-80, attending hospital diabetes clinic. All practices in area of study (2 declined). Excluded: Major diabetic complications or other medical conditions requiring hospital attendance. bag by an independent person) Included: Stabilised NIDDM or IDDM patients. Referred to clinic by GPs for assessment management over a 12- month. Excluded: Serious diabetic complications or other medical conditions. Of 246 patients, 206 were eligible. HOS+GP: 197; 58 GPs HOS: 97; GP: 103 HOS: 65; GP: 72; SC: 69 2 years 5 years 1 year Not recorded HOS: 3; GP: 9 At 1 year clinic assessment: HOS: 47%; GP: 43%; SC : 39% Endpoint analysis Endpoint analysis Endpoint analysis No significant differences between groups in symptoms, limb function, fundi, blood pressure, weight, blood sugar urine analysis. (Data not presented.) Mortality (count): GP: 17; HOS: 8 GP care was reported to cost half of hospital care but no details are provided. Seen at least once a year: GP: 14 (13.6%); HOS 97 (100%); p< Hospitalisation (medical): GP: 25 (24%); HOS 17 (18%); p=0.24 Mortality: GP: 18 (17%); HOS: 6 (6%); p=0.014 HbA 1c (SD): GP: 10.4±1.73%; HOS: 9.5±1.77%; p<0.02 None. Attendance rate at 4 monthly reviews: Visit 1: HOS: 80%; GP: 32%; SC: 82% Visit 2: HOS: 59%; GP: 28%; SC: 75% Visit 3: HOS: 53%; GP: 35%; SC: 72% Attendance at 1 year complication assessment: HOS: 53%; GP: 57%; SC: 61% HbA 1c (SD): HOS: 7.3±1.6%; GP: 6.9±1.3%; SC: 6.6±1.6%; p=ns; Incremental costs between groups following stabilisation assessment, based on charges ranked clinical care as the most costly per patient year ($205), then shared care ($135) GP care ($105). The prevention management of foot problems 109

8 Appendix 2 (contd): Organisation of care: trials Trial Hurwitz et al, 1993 DICE, 1994 Treatment HOS: Continuing hospital diabetes clinic comparison(s) GP: Prompted general practitioner care Other features GP patients: A computer database sent requests every six months to patients for blood urine samples to be taken in a local health centre or in hospital. were sent to patients who were requested to visit their GP within 10 days for review. Annual eye review at a local optometrist was also prompted. Review could occur at hospital as well as with the GP. The database compiled results provides patient details for referral visits. Location London, Engl (urban), 38 general practices, 11 optometrists, 2 hospital outpatient clinics in Islington Baseline comparability at p>0.05 Yes, except: HOS: Greater mean systolic blood pressure GP: More patients with leg ischaemia Blinding level None None Concealment Not clear (Cambridge tables of rom numbers) Not reported of al Inclusion/ exclusion Length of follow-up Loss to follow up (%) Type of analysis Outcomes/ endpoints Economic data Included: Mobile NIDDM patients <80 years of age. Excluded: Women of child bearing age, significant levels of diabetic complication Of 570 patients: 415 were eligible; 215 agreed to participate; 209 ; 28 excluded after romisation; 181 analysed. HOS: 92; GP: 89 HOS: 135; GP: years (median) 2 years Not recorded HOS: 24; GP: 15 Endpoint analysis Seen at least once: GP: 86/89 (96.6%); HOS: 78/92 (84.8%); p=0.013 Number of reviews/patient/year (mean±sd) GP: 3.0±3.8; HOS: 2.4±1.3; p=ns Hospitalisation (diabetes related): GP: 8/89 (9%); HOS: 17/92 (18%); p=ns Referral to dietitian: GP: 29/86 (34%); HOS: 32/78 (41%); p=ns Referral to chiropodist: GP: 7/86 (8%); HOS: 10/78 (13%); p=ns Mortality: GP: 7/89 (8%); HOS: 7/92 (8%); p=ns HbA 1c (mean±sd) GP: 10.3±2.3 %; HOS: 10.6±2.5 %; p=ns HOS: Continuing hospital diabetes clinic GP: Integrated general practitioner care A computer-based record system was used. GP: Patients were sent reminders to visit their GP every 3 to 4 months annually at the clinic. Clinicians were given written guidelines for care, were prompted when a visit was due sent a record card for return on completion. HOS: Patients were sent routine clinical appointments. Grampian, Scotl (urban/coastal mix) Hospital diabetes clinic in Aberdeen 3 general practices Yes Included: Stabilised NIDDM or IDDM patients. Excluded: <18 years of age, pregnant or planning pregnancy, serum creatinine >200 µmol/l, medical problems requiring clinic attendance. Of 311 patients: 284 were eligible; 274 agreed to participate. Endpoint analysis Reviews/patient in 2 years, (mean±sd): GP: 5.3±1.4; HOS: 4.8±1.7; p<0.05 Foot assessments/patient in 2 years (mean±sd): GP: 1.4±1.0; HOS: 0.5±0.6; p<0.05 Seen by dietician: GP: 32/124 (26%); HOS: 44/111 (40%); p<0.05 Seen by chiropodist: GP: 72/124 (58%); HOS: 29/111 (26%); p<0.05 Mortality: GP: 11/124 (7.5%); HOS: 10/111 (7.9%); p=ns HbA 1c (mean±sd): GP: 5.3±1.7 %; HOS: 5.3±1.7 %; p=ns Clinic care was estimated to cost 55 /patient year; integrated care was based on data from two practices. The practice with the lower cost care used routine surgeries to see patients whereas the practice with the higher cost provided weekly diabetes mini-clinics run by one doctor. 110 Clinical Guidelines for Type 2 Diabetes

9 Appendix 2 (contd): Organisation of care: trials Author (s) Study Type of intervention Setting Mean age±sd (years) Male/female ratio Follow-up Donohoe ME et al, 2000 Cluster trial T1: integrated care model centred on primary care-based annual review at which GP or practice nurse examines patients feet, plus package of supportive complementary educational initiatives to clarify contemporary management of diabetic foot, referral criteria, responsibilities of professionals. Items included: practice visits over 6 months, training, introduction of monofilament, guidelines for referral to chiropody specialist diabetic foot clinic, foot care leaflets for patients, training for chiropodists. T2: practice visit with unrelated educational intervention (diabetic nephropathy) continuation of current foot care arrangements Primary care Practices T1: 5 T2: 5 Patients T1: 981 T2: 958 Responders T1: 858 T2: 810 Inclusion at practice level: existence of diabetes practice register, structured approach to diabetes care, defined relationship with chiropodist, Type 1 or Type 2. Exclusion of patients: if GP considered them unable to complete a questionnaire T1: 66.7 ( ) T2: 64.8 ( ) T1: M463, F395 T2: 427, F383 6 months Primary outcomes: Patient s attitudes towards foot problems Patients foot care knowledge Healthcare professionals knowledge Secondary outcomes: Appropriateness of referrals to specialist foot clinic to community chiropody clinics The prevention management of foot problems 111

10 There were significant differences between responders non-responding patients by age, HbA 1c percentage with Type 1 diabetes (all p<0.001). Patients: Attitudes No differences in baseline attitude scores between T1 (81.1%) T2 (81.9%) (p=0.32). Improvement in overall attitude towards their foot care over time, T1: 3.9 (p<0.001) T2: 0.7 (p<0.001). Mean change in attitude significantly greater in T1 vs T2 (p=0.01). Attitude towards patients personal foot care responsibilities improved in T1: by 2.5% (p<0.001) vs T2 decrease of 0.2%, difference in change between T1 T2 (p=0.027). Attitude towards foot care provided increased in both groups, T1: 3% (p<0.001), T2: 1.8% (p<0.001), with no difference in change between T1 vs T2 (p=0.26). Knowledge No differences in baseline mean percentage knowledge scores, T1: 65.6%, T2: 66.0% (p=0.549). Improvement in knowledge scores in both groups, with mean percentage change, T1: 1.1 (p=0.015), T2: 1.3 (p=0.002), with no difference in change between T1 vs T2 (p=0.54). Foot examination More patients had their foot examined in T1 vs T2 (p<0.001), received foot care education (p<0.001) found the education useful (p=0.03). No difference between T1 vs T2 in numbers receiving an annual review (p=0.35) Healthcare professionals No difference in baseline knowledge scores between T1: 33.3% T2: 33.0% (p=0.88). Knowledge scores improved in T1 difference between T1 T2 became significant (p=0.008). Service utilization Increase in number of appropriate referrals to specialist foot clinic, particularly those with high risk feet having inappropriate footwear in six months following intervention vs six months before intervention in T1: before 9/13, after 26/28, (p=0.046), but no changes in T2: before 8/10, after 10/10 (p=0.14). At baseline, in T1: 31/40 (78%) T2: 33/42 (79%) of consecutive diabetes patients attending subservient community chiropody clinics were deemed at high risk of ulceration hence appropriate. No improvements seem at follow up, T1: 28/40 (70%), T2: 31/45 (69%) consecutive patients. Costs Total costs of providing educational programme to five intervention practices, including primary secondary care time attending educational sessions cost of materials was 4216 Provision of integrated care arrangements for the diabetic foot can have a positive impact on the knowledge of primary care staff attitudes of patients, resulting in increased number of appropriate referrals to acute specialist services. 112 Clinical Guidelines for Type 2 Diabetes

11 Appendix 3: Patient education: systematic review Author (s) Valk DMW et al, 2002 also Valk et al 2002 End search date March 2001 Study Type of intervention Setting Systematic review of 8 controlled trials (6 of which were in the original guideline evidence). 9 rejected (4 were in the original guideline. (note: paper says 19 considered but gives no details on those rejected, Cochrane review gives 8 included, 9 rejected, with details). 4 compared intensive foot care education with brief education. 1 compared single group education session on foot care skin hygiene with no intervention. 2 compared patient education on diabetes in general including foot, tailored to individual patient needs, with usual care. 1 offered modules of instruction depending on educational needs, 1 of which covered foot care. 1 targeted specific areas of diabetes self management with greatest need. 1 compared diabetic foot prevention with usual care. Home environment (1) primary care (3) podiatry outpatient care (1) outpatient (3) Inclusion: prospective RCTs evaluating educational programmes for prevention of foot ulcer in people with diabetes mellitus, Type 1 or Type 2, subjects aged 18 years. Exclusion: studies solely aimed at optimising blood glucose levels, those lacking explicit focus on foot care. Methodological quality of all included RCTs was poor. Mean age±sd (years) Followup Primary: Incidence of foot ulceration, infection, amputation, ulcer recurrence. Secondary: callus development, resolution of callus, number duration of hospital admissions for diabetic foot problems, foot care knowledge, patients behaviour assessment. The reviewers concluded that patient education may have positive, but short-lived, effects on foot care knowledge behaviour in patients with diabetes may reduce foot ulceration amputations, especially in high risk patients. But the quality of the evidence was poor. The prevention management of foot problems 113

12 Appendix 3 (contd): Patient education: trials (selected endpoints) Trial Rettig et al, 1986 Bloomgarden et al, 1987 Malone et al, 1989 Treatment comparison(s) Other features INT: Home education (general diabetes care foot care) provided by nurse CON: Not receiving home education INT: Patients received a nurse home visit completed a needs assessment survey at baseline. Information obtained led to a tailored program of instruction. The number of educational home visits varied, with a maximum of 12. Education areas were diet, urine testing, medication foot care. No charge was made for participation INT: Nine education sessions (general diabetes care foot care) in addition to usual care CON: Usual care INT: Patients attending at least 7 sessions were considered graduates. Patients were attending a diabetes clinic. Approximately 90% of enrolees were black or Hispanic. The program lasted 1.6±0.3 years in the education group, with 1.5±0.3 years of care in the control group. INT: One education session (foot care) in addition to usual care CON: Usual care Usual care: hospital patients with diabetes received routine diabetes teaching on diet, weight, medication, exercise medication. INT: Patients received a 1-hour educational class which included a slideshow of infected feet amputated limbs, a patient instruction checklist. Location Nebraska, USA New York, USA Arizona, USA Baseline comparability Yes Yes, except: CON: Foot lesions more common Yes, except INT: foot callus more common at p>0.05 INT: Higher fasting blood glucose, higher number of hospitalisations in previous year Blinding level No effective blinding None apparent None apparent Concealment of al Not clear Not clear Yes (based on odd/even last digit of Social Security number) Inclusion/ exclusion Length of follow-up Loss to follow-up (%) Type of analysis Outcomes/ endpoints Economic data Inclusion: NIDDM IDDM, <65 years old, not terminally ill, inclusion approved by own physician. Less than 30% of inpatients with diabetes were eligible. About 70% of eligible patients enrolled Inclusion: Type I Type II Diabetes. Of 749 eligible patients receiving primary care at the diabetes clinic, 302 were enrolled. Inclusion: NIDDM IDDM patients referred for podiatry or surgery, following treatment, with uninfected foot ulcers or prior amputation. Exclusion: Patients requiring wound debridement, formal incision drainage of infection, amputation or vascular reconstruction. INT:228; CON: 243 INT: 145; CON: 157 INT: 103 (203 limbs); CON: 100 (193 limbs) 6 months for primary endpoints, Mean 1.5 years INT: mean 13.2 months; CON: mean 9.2 telephone survey at 12 months for months clinical consultations hospitalisations INT: 21%; CON: 21% INT: 12%; CON: 11% INT: 13; CON: 8 Endpoint analysis Endpoint analysis Endpoint analysis Assessed by nurse at 6 months: Foot care knowledge score (mean ±SE): INT: 60.2±1.3; CON: 51.6±1.4; p=0.001 Foot care skill score (mean ±SE): INT: 71.8±2.0; CON: 68.9±1.8; p=ns Foot appearance score (mean ±SE): INT: 70.2±0.7; CON: 68.8±0.7; p=ns Assessed by telephone survey at 12 months: Preventable diabetes related hospitalisation rates (per 1000 subjects/year ±SE): INT: 94.4±35.8; CON: 41.5±16.1; p=ns Preventable diabetes related inpatient length of stay (mean ±SE): INT: 6.88±1.54; CON: 6.13±1.17; p=ns Home education was costed at $175 per patient although no details are provided. Assessed by interviewer at 18 months: Knowledge score (mean ±SD): INT: 5.8±1.6; CON: 5.3±1.7; p= Behaviour score (mean ±SD): INT: 4.3±1.6; CON: 4.1±1.6; p= HbA 1c (mean ±SD): INT: 6.1±2.0; CON: 6.3±2.0; p= Foot lesions (minor severe), at final evaluation: INT: 51%; CON: 65%; p=ns (56% of the intervention group were considered graduates: this sub-group scored consistently better than nongraduates in knowledge behaviour scores) Not reported. Clinically assessed at 2 years: Limbs without infection, ulcer or amputation: INT: 160/177 (90)%; CON: 128/177 (72%); p Infected limbs: INT: 2/177 (1%); CON: 2/177 (1%); p=ns Ulcerated limbs: INT: 8/177 (5%); CON: 26/177 (15%); p Amputated limbs: INT: 7/177 (4%); CON: 21/177 (12%); p Mortality: INT: 3%; CON: 4%; p=ns Statistical calculations assume independence of limbs no influence of different duration of follow-up. Simple calculations based on charges are used to explore the probable cost-saving nature of intervention. 114 Clinical Guidelines for Type 2 Diabetes

13 Appendix 3 (contd): Patient education: trials (selected endpoints) Trial Barth et al, 1990 Kruger et al, 1992 Treatment comparison(s) Other features INT: Four special foot care sessions in addition to normal education programme CON: Normal education programme Recruitment by radio newspaper campaign, general practice referral diabetes clinic referral. Patients received either conventional or intensive education in groups of CON: 14 hours over 3 consecutive days (including foot care: 1 hour session). INT: Additional 4 weekly sessions of hours (total 9 hours) on foot care using motivational techniques. A podiatrist took 3 sessions a psychologist one. INT: Participatory education (foot care) in addition to usual care CON: Usual care The study enrolled patients entering a hospital diabetes programme. Usual care: Videotape supplementary explanation from an instructor on foot care. Patients were encouraged to examine their feet daily given a daily checklist. INT: Participatory hs-on teaching/learning sessions (actual foot washing, inspection, care of corns calluses, cutting toe-nails, evaluating problems suitable footwear). Patients received an education kit with materials (buff pads an inspection mirror). Location Sydney, Australia Wichita, USA Baseline Yes, except: INT: Greater peripheral vascular Not reported comparability at p>0.05 disease Blinding level Assessment by an independent, blinded podiatrist None apparent Concealment of al Not clear Not clear; romisation by odd/even week of enrolment Inclusion/ exclusion Length of follow-up Loss to follow-up (%) Type of analysis Outcomes/ endpoints Economic data Inclusion: Type II diabetes, >30 years old, duration of diabetes >3 months, duration of current treatment >1 month, sub-optimal glucose control HbA 1 9.5%; overweight (BMI 25 kg m -2 ); energy intake as fat 35%; no diabetes education in last 6 months; no major physical or mental disabilities. Out of 350 volunteers, 86 passed the entrance criteria, 70 were. INT: 32; CON: 38 INT: 23; CON: 27 6 months 6 months Inclusion: NIDDM IDDM patients of 5 years duration no major complications. INT: 5; CON: 3 INT: 8 (35%); CON: 12 (44%) Endpoint analysis Assessed by a podiatrist at baseline, 1, 3, 6 months: (Analyses using repeated with baseline covariates) The intensive care group showed significantly greater improvement in foot care knowledge (p<0.001) compliance with foot care routine (p=0.012). However, both groups showed significant improvement over time differences in absolute scores were small at 6 months, approximately 2/12 for knowledge 1/12 for compliance. The intensive care group showed significantly greater compliance with advice to consult a podiatrist (p=0.008) a greater reduction in foot problems (p<0.006) at 1 month but neither of these effects were significant at 6 months. Not reported. Endpoint analysis Assessed by trialists: Knowledge score: INT: 19/23 (83%); CON: 22/27 (82%); p=ns Self reported : Daily foot inspection: INT: 10/15 (66.7%); CON: 10/15 (66.7%); p=ns Daily foot washing: INT: 13/15 (86.7%); CON:11/15 (73.3%); p=ns Use of pumice stones for corns: INT: 4/15 (26.7%); CON: 4/15 (26.7%); p=ns Trimming toenails regularly: INT: 12/15 (80.0%); CON: 10/15 (66.7%); p=ns Improvement in keeping toenails shorter: INT: 12/15 (80.0%); CON: 13/15 (86.7%); p=ns No significant differences were found in assessment skills, neurometer readings, or assessment of photographs of feet by podiatrists. The prevention management of foot problems 115

14 Appendix 3 (contd): Patient education: trials (selected endpoints) Trial Litzelman et al, 1993 Pieber et al, 1995 Treatment comparison(s) Other features INT: Participatory education (foot care) in addition to usual care CON: Usual care Patients in a general medicine practice received a risk assessment interview concerning foot behaviour care at baseline. INT: Patients received foot-care education (in groups of 1 4) conducted by nurse clinicians entered into personalised behavioural contracts, reinforced by telephone postcard reminders at 1 3 months. Health care providers were given practice guidelines, informational flow sheets prompts to perform visual examination provide education. INT: Education (general diabetic care foot care) in addition to usual care in general practice CON: Usual care 14 participating single-hed GPs were divided to form INT (7) CON (7) GP groups. All office examinations were made by a specially trained medical student. INT: Patients (in groups of 4-8) received 4 weekly sessions (1½ -2 hours each) covering a range of aspects of diabetic care. Location Indiana, USA Styria, Southern Austria (rural) Baseline INT: HbA 1c greater (p=0.01). Yes comparability at p>0.05 Blinding level None apparent None apparent Concealment of al Not clear; romisation by primary care team Not clear, romisation by practice, but criteria for choosing intervention practices not given Inclusion/ exclusion Inclusion: NIDDM, age >40 years, receiving care at the practice for the next 2 years, body weight ideal or heavier Inclusion: Type II diabetes, absence of any physical or mental hicap preventing compliance with the programme. than ideal. Exclusion: Pregnancy, major psychiatric illness, terminal illness, renal failure, previous bilateral amputations, inability to provide any aspect of self care Of 728 eligible patients, 484 agreed to participate, 395 attended the baseline assessment. INT: 191; CON: 205 INT: 52; CON: 55 Length of 1 year 6 months follow-up Loss to INT+ CON: 43 (11%) INT: 7 (13%); CON: 6 (11%) follow-up (%) Type of Endpoint analysis Endpoint analysis analysis Outcomes/ endpoints Economic data Serious foot lesions at 1 year (compared to baseline prevalence of 2.9%): Odds Ratio (INT vs. CON) = 0.41; 95%CI: 0.16 to 1.00; p=0.05 Any foot lesions at 1 year (compared to baseline prevalence of 10.5%): Odds Ratio (INT vs. CON) = 0.65; 95%CI: 0.36 to 1.17; p=0.15 Self reported care, (mean±sd) (12 questions: 1=almost always, 5=almost never): INT: 1.90±0.42; CON: 2.12±0.49; p= Foot examination during office visits: INT: 68%; CON: 28%; p<0.001 Receiving foot-care education from health care providers: INT: 42%; CON: 18%; p<0.001 Referral to podiatrist: INT: 10.6%; CON: 5.0%; p=0.04 Amputations: INT: 0.5%; CON: 2.0%; p=0.20 Analysis is conducted at the level of the patient but romisation was at the level of the primary care team. The validity of the statistics presented is uncertain. The cost of the materials was estimated to be less than $5000. Other costs are not estimated. Diabetes-related knowledge (% correct answers, SD) INT: 69±21; CON: 40±19; p=0.001 Callus formation: INT: 22/45 (49%); CON: 40/49 (82%); p<0.001 Interdigital cracks, fissures or mycosis: INT: 22/45 (49%); CON: 32/49 (65%); p<0.05 Analysis is conducted at the level of the patient but romisation was at the level of the GP. The validity of the statistics presented is uncertain. Introducing the intervention was estimated to reduce health care costs by 33/patient/year, while costs rose in the control group by 30. These changes were mainly due to changes in prescribing of oral hypoglycaemic agents. No details of the costings are given. 116 Clinical Guidelines for Type 2 Diabetes

15 Appendix 3 (contd): Patient education: trials (selected endpoints) Author (s) Study Type of intervention Setting Mean age±sd (years) Follow-up Campbell EM et al 1996 Romised trial T1: minimal instruction programme (2 x 1hr sessions delivered within 2 weeks of referral) T2: education programme of individual visits (2 x 1hr sessions delivered within 2 weeks of referral by nurse dietician, plus monthly sessions, 30 minutes long with nurse until 12 months from initial session T3: educational programme incorporating a group education course (at least 2 individual sessions followed by a 3 day course, further 2hr group follow-up sessions at 3 9 months after course. Course sessions provided by nurse educator, dietician, occupational therapist, podiatrist. 1 x 2hr diet lecture optional). T4: a behavioural programme (individual visits from nurse educator, 3 in first month, then a minimum of one at 3, 6 12 months interspersed with telephone calls from educator. All sessions except first in patient s home). Diabetes Education Service, general practice, Newcastle, Australia T1: 59 T2: 57 T3: 66 T4: 56 Inclusion: Type 2 diagnosed < 5 years, <80 years of age, able to speak, read underst English, received no previous formal instruction in diabetes care, not taking >75% of maximum dosage of oral hypoglycaemic agents, not terminally ill. Exclusion: Not stated T1: 58.2±1.3 (SE) T2: 58.4±1.4 T3: 56.8±1.5 T4: 60.9±1.4 T1: M22, F37 T2: M35, F31 T3: M33, F24 T4: M24, F32 3,6 12 months Process: Checklist completed by educators for each consultation audio-taped consultation. Outcome: blood glucose, diabetes treatment, BMI, blood lipids, blood pressure, smoking, diabetes knowledge, patient satisfaction with diabetes education, consultation with podiatrist, ophthalmologist, utilisation of medical services No difference between the 4 groups for age sex at baseline. Percentage change from baseline to 3 months in numbers consulting a podiatrist, T1 12%, T2: 21%, T3: 10%, T4: 43%, (p=0.003, T1 vs T4, T2 vs T4 T3 vs T4 all sig differences) Percentage change from baseline to 6 months in numbers consulting podiatrist, T1: 27%, T2: 53%, T3: 33%, T4: 65% (p=0.005, T1 vs T4, T3 vs T4 all sig differences) Percentage change from baseline to 12 months in numbers consulting a podiatrist, T1 no info, T2 73%, T3: 55%, T4: 74% (p>0.05) Behavioural programme most effective in promoting podiatrist consultations. The prevention management of foot problems 117

16 Appendix 3 (contd): Patient education: trials (selected endpoints) Author (s) Study Type of intervention Setting Mean age±sd (years) Followup Hamalain en H et al 1998 Romised trial, romisation within separate sex age groups, split <2 years>. T1: podiatrist care (individual counselling primary prevention, treatment by podiatrist as required, all provided free for 1 year) T2: control group, written instructions only Helsinki, Finl T1: 267 T2: 263 At 1 year FU T1: 233 T2: 226 At 7 year FU T1: 169 T2: 163 Inclusion: on National Drug Reimbursement Register, aged years, living in Turku or surroundings, Type 1 or Type 2. Exclusion: visited podiatrist in preceding 6 months continuing to receive care, needing foot care for infection, ulcer, amputation. Mean age of total group, which has approx 100 patients in each age stratum. (n=733) 46.9± years Information about diabetes Podiatric examination Knowledge scores similar in T1 T2 at baseline, improved in both groups (p<0.001) both sexes (p<0.001) over 7 years. Level of knowledge higher in T1 compared with T2 at 1 year FU (p=0.025). Self care scores similar in T1 T2 at baseline but women had higher scores than men at baseline (p<0.001) in FU. Men s scores increased significantly over time but no difference between T1 T2 (p=0.186). For women, scores also increased over time (p<0.001) but greater increases seen in T1 compared with T2 (p=0.011) over FU with greatest changes in year 1. Visits to podiatrist: Baseline T1 T2 Seven year FU T1 T2 never visited 73.4% 76.1% 17.7% 50.3% not visited within last 6 years 12.4% 10.4% 30.8% 25.2% visited between 1 6 years ago 14.2% 13.5 (p=0.819) 51.5% 24.5% (p<0.001) No differences between T1 T2 for number of patients whose feet had been inspected by a physician during a routine examination or because of foot problems requiring a visit to a doctor (p>0.05). No difference between T1 T2 for other foot abnormalities (all P>0.05). Counselling improved podiatrist visits but did not make any difference to prevalence of foot lesions. 118 Clinical Guidelines for Type 2 Diabetes

17 Appendix 4: Risk factors: foot ulceration Author (s) Frykber g RG et al, 1998 Study Type of intervention Setting Cross-sectional (baseline data for prospective study) 3 diabetic foot centres, USA None N=251 Inclusion: all attending diabetic foot centre, Type 1 or Type 2. Exclusion: none stated Mean age±sd (years) 58.5±12.5 (20-83) M126, F125 Caucasian 121, Black 36, Hispanic 94 Followup None Foot ulceration associated with: demographic factors, diabetes-associated factors Type 1: 49 Type 2: 202 Multivariate logistic regression, controlling for age, diabetes duration, sex, race, (all p<0.05), other predictors of ulceration were maximum peak plantar pressures 6kg/cm2, (OR 2.1, 95% CI 1.3, 3.4, p=0.002), vibration perception threshold 25V (4.4, 2.6, 7.5, p<0.0001), Semmes-Weinstein monofilament tests 5.07 (4.1, 1.89< 8.87, p<0.001). Presence of pulses body mass index were protective in univariate analysis but not significant after adjustment for other covariates. Multivariate logistic regression for ulceration by race, after adjustment for age, duration of diabetes sex, showed some variation between the three races studied. For Caucasians, the risk factors were as above, maximum peak plantar pressure (OR 7.7, 95% CI 2.07, 28.4, p=0.002), vibration perception (7.4, 2.4, 22.9, p=0.001), monofilament tests (3.7, 1.3, 10.3, p=0.013). For Black, peak plantar pressures were not significant (OR 0.53, 95% CI 0.05, 5.8, p=608) but vibration perception (7.2, 1.2, 43.7, p=0.032), monofilament tests (19.8, 1.1, 344.2, p=0.041) were. For Hispanic, only vibration perception was significant (OR 6.6, 95% CI 2.3, 18.5, p<0.001). Note CI very wide. The prevention management of foot problems 119

18 Appendix 4 (contd): Risk factors: foot ulceration Author (s) Sriussad aporn et al 1997 Study Type of intervention Setting Case control Cases: Type 2 with foot ulcers Controls: Type 2 without foot ulcers Diabetic clinic, Bangkok, Thail None T1: 55 T2: 110 Inclusion for cases: Type 2, foot ulcers duration >14 days, severe infection, necrosis or gangrene Exclusion: both groups past history of foot ulcer, lower limb amputation, chronic venous ulcer, cerebrovascular disease, spinal cord disease. Mean age±sd (years) Ages not stated Cases: M13, F42 Controls: M27, F83 Followup Foot ulceration associated with: Demographic factors Clinical characteristics Peripheral vascular status Diabetic-related factors Diabetic knowledge foot care behaviour No differences in age sex between cases controls. Multiple logistic regression analyses showed that the risk of developing foot ulcers in patients with diabetes was independently associated with three factors: short-latency somatosensory evoked potentials following stimulation of the tibial nerve (OR 1.67, 95% CI 0.31, 8.97, p<0.001), visual acuity (OR per unit decrease in decimal visual acuity, 95% CI 0.005, 0.39, p<0.005), fasting blood glucose level (OR 1.01 per mmol/l increase, 95% CI 1.00, 1.02, p<0.005). Other variables significant at the univariate level but not following multiple logistic regression were: HbA1c, urea, creatinine, diabetic knowledge score, foot care score. Peripheral neuropathy, visual impairment poor glycaemic control are major risk factors associated with foot ulceration in Thai Type 2 patients. 120 Clinical Guidelines for Type 2 Diabetes

19 Appendix 4 (contd): Risk factors: foot ulceration Author (s) Study Type of intervention Setting Mean age±sd (years) Ages not stated Followup El- Shazly M et al, 1998 Case control 17 out of 20 Italian regions, 35 diabetes outpatient clinics 49 general practitione rs offices None Cases: 348 Control: controls enrolled for each case Inclusion: Type 1 or Type 2 of 5 years duration. Cases: foot ulcer, claudication, gangrene /or ischaemic rest pain lasting 15 days, bypass or angioplasty for peripheral vasculopathy, amputation <12 months Controls: None of above complications of lower limb. Cases: M220, F128 Controls: M490, F 560 Cases: NIDDM 94, NIDDM with insulin 209, IDDM 45 Controls: NIDDM 563, NIDDM with insulin 332, IDDM 155 None Lower extremity complications associated with: Demographic data Socioeconomic data Clinical variables Healthcare related variables Patient practice Multivariate logistic regression analysis showed that: Males had higher risk of developing lower extremity complications than females (OR 2.5, 95% CI 1.6, 309) Patients aged years had higher probability of being a case than those under 50 (OR 3.6, 95% CI 2.1,6.3) or over 70. Single patients more likely to develop a lower limb complication than married ones (OR 1.4, 95% CI 1.1, 1.8) Increased risk of complications was seen in IDDM patients (OR 3.9, 95% CI 11.4, 10.7) NIDDM with insulin (1.4, 1.1,2.8) compared to NIDDM. Diabetic neuropathy was strongly positively related to lower limb complications (OR 3.0, 95% CI 2.1, 4.2) Presence of cardiac or cerebrovascular diseases was associated with an increased complication risk (OR 1.5, 95% CI 1.2, 1.8). Poor metabolic control gave higher risk of complications (OR 1.32, 95% CI 1.1, 1.4) Patients who needed help in reaching the healthcare facility before the development of the complication showed a higher risk of complications (OR 1.4, 95% CI 1.1, 2.2) Patients who did not attend follow-up visits regularly were at greater risk (OR 2.0, 95% CI 1.3, 3.0). Patients who had never received any kind of health education were more likely to be a case compared with those who regularly received educational information (OR 3.1, 95% CI 1.3, 89.0). Education, employment, diabetic retinopathy, nephropathy, hypertension, diabetes duration, smoking, alcohol consumption were not significant factors. The prevention management of foot problems 121

20 Appendix 4 (contd): Risk factors: foot ulceration Author (s) Study Type of intervention Setting Mean age±sd (years) Vibration threshold <25V 57.1±7.7 Vibration threshold 25V 62.6±7.3 Followup Kastenba uer T et al, 2001 Prospective Diabetes centre, Vienna, Austria None N=187 Dropouts N=25 (13%) Inclusion: Type 2, no history of foot ulcer or lower limb amputation, <75 years of age Exclusion: past or current foot ulcers, lower extremity amputation, severe peripheral arterial disease (intermittent claudication), severe neurological deficits due to other diseases than diabetes, presence of any other cause of peripheral neuropathy, Charcot s foot Vibration threshold <25V M 45.9, F54.1 Vibration threshold 25V M76.9, F23.1 Every year for mean of 3.6 years (461.9 person years) Incidence of foot ulceration Ulcer free survival Risk factors for foot ulceration 52 patients had elevated vibration perception thresholds at baseline ( 25V). Ten patients developed 18 neuropathic foot ulcers during follow-up, nine of which had an elevated perception threshold at baseline. Annual incidence of foot ulceration was 1.6% (95% CI 0.7, 2.6). Incidence density of first foot ulceration (n=10) was 21.7 per 1,000 person-years (95% CI 8.2, 35.1). Six of the patients who developed an ulceration incurred eight recurrent foot ulcers, five of those with repeat ulceration had an elevated vibration perception threshold. Patients with foot ulcers were: significantly heavier, 90.9±12.8kg vs 82.1±13.3kg (p=0.04) had significantly lower peroneal nerve conduction velocity, 37.1±4.5m/sec vs 43.1±4.5m/sec (p=0.02) had significantly higher vibration perception thresholds, 36.8±8.6V vs 17.6±9.2V (p<0.0001) Age, duration of diabetes, HbA1c were not significantly different in the two groups. Those with ulcers, 70% had symptoms of sensory neuropathy at baseline but none lacked perception of the 10g monofilament. Factors most predictive for foot ulceration (multiple Cox proportional hazards regression analysis) were: Elevated vibration perception threshold (RR % CI 3.1, 205, p=0.0024) Mean plantar pressure >2SD in at least one forefoot region (RR 5.1, 95% CI 1.2, 32.7, (p=0.0291) Daily alcohol intake (no quantities) (RR 5.1, 95% CI 1.1, 24.0, p=0.0404) Mediasclerosis (RR 0.07, 95% CI 0.01, 0.6 p=0.0174) 122 Clinical Guidelines for Type 2 Diabetes

21 Appendix 4 (contd): Risk factors: lower limb complications Author (s) Study Type of intervention Setting Mean age±sd (years) Median 65 years (28-91) Followup Adler AI et al, 1999 Seattle Diabetic Foot Study Prospective General medicine clinic, Seattle, USA None N=776 Inclusion: outpatients in general medicine clinic of Veterans Affairs, with diabetes, Type 1 or Type 2 Exclusion: too ill to participate, unable to walk, unable or declined to consent M 98.2% White 78% Type 1: 51, Type Median 3.3 years (0-5.8), 2305 patientyears Peripheral sensory neuropathy (10 g Semmes-Weinstein monofilament) Peripheral vascular disease Foot ulcer Lower limb amputation, time to amputation Three multivariate models used incorporating different measurements or peripheral vascular disease: ankle arm index, transcutaneous oximetry, palpation of posterior tibialis dorsalis pedis pulses. Irrespective of model, former amputation, lower extremity ulcers, peripheral sensory neuropathy, treatment with insulin were associated with an increased risk of lower limb amputation when controlling for duration of diabetes. Peripheral sensory neuropathy only achieved significance in the model in which peripheral vascular disease was measured by oximetry. The crude incidence rate for lower limb amputation was 13.4 per 1,000 patient years. Age stardised incidence rate per 1,000 patient years of follow-up for men was Peripheral sensory neuropathy, foot ulcers, peripheral vascular disease, former amputation treatment with insulin are independent risk factors for lower limb amputation in people with diabetes. The prevention management of foot problems 123

22 Appendix 4 (contd): Risk factors: lower limb complications Author (s) Study Type of intervention Setting Mean age±sd (years) Median 65 years (28-91) Followup Boyko EJ et al, 1999 Seattle Diabetic Foot Study Prospective General medicine clinic, Seattle, USA None N=776 (1483 lower limbs) Inclusion: outpatients in general medicine clinic of Veterans Affairs, with diabetes, Type 1 or Type 2 Exclusion: too ill to participate, unable to walk, unable or declined to consent M 98.2% White 78% Type 1: 95 (lower limbs) Type 2: 1388 (lower limbs) Fu at month intervals Mean 3.7 years (0-5.8), 2305 patientyears Peripheral sensory neuropathy (10 g Semmes-Weinstein monofilament) Peripheral vascular disease Foot ulcer Two Cox proportional hazards models used, with without inclusion of orthostatic blood pressure drop, because of missing orthostatic blood pressure data. In the first model, including orthostatic blood pressure drop, the variables associated with risk of foot ulcer were: sensory neuropathy by 5.07 monofilament (RR 2.17, 95% CI 1.52, 3.08, p<0.001), history of foot ulcer (RR 1.63, 95% CI 1.17, 2.26, p=0.004), history of amputation (2.81, 1.84, 4.29, p<0.001), insulin use (1.59, 1.14, 2.22, p=0.006), transcutaneous oximetry dorsal foot (mm Hg) (0.8, 0.69, 0.93, p=0.004), weight (kg) (1.23, 1.06, 1.43, p=0.006), log ankle arm index (0.83, 0.73, 0.96, p=0.011), Charcot deformity (3.49, 1.22, 9.92, p=0.019), vision <20/40 (1.93, 1.42, 2.63, p<0.001). The only difference between model 1 model 2 is that Charcot foot is no longer significantly associated with foot ulcer. Two interactions observed between past history of foot ulcer hammer toe deformity (p=0.006) poor vision laser photocoagulation history (p=0.049). 124 Clinical Guidelines for Type 2 Diabetes

23 Appendix 4 (contd): Risk factors: lower limb complications Author (s) Study Type of intervention Setting Mean age±sd (years) Followup Peters EJG & Lavery LA, 2001 Prospective case control to evaluate effectiveness of diabetic foot risk classification (International Working Group on the Diabetic Foot). Health Science Centre, Texas, USA None N=236 FU N=213 Inclusion: diabetes, Type not stated Exclusion: Any receiving amputation were disqualified from further analyses 52.6±10.4 Mean 30 months Foot ulcer Amputation Peripheral arterial bypass Patients allocated to one of four groups: group 0, no neuropathy, Group 1 neuropathy, Group 2 neuropathy, vascular disease /or deformity, Group 3 previous ulcer. There were significantly more ulcerations amputations (p<0.001) in higher risk groups. All amputations were found in Groups 2 3 (3.1% 20.9%, p<0.001). During 3 years of follow-up, ulceration occurred in 5.1, 14.3, % of the patients in groups 0, 1, 2, 3 respectively (linear by linear association p<0.001). Patients in Group 3 were 34.1 times (95% CI 11.0, 105.8) to develop an ulcer in the follow-up. The prevention management of foot problems 125

24 Appendix 4 (contd): Risk factors: lower limb complications Author (s) Study Type of intervention Setting Mean age±sd (years) Men, East Finl 56.8±0.3 Men, West Finl, 57.2±0.3 Women, E Finl 58.9±0.3 Women W Finl 58.7±0.3 Followup Lehto S et al, 1996 Cohort Finl None N=1044 Inclusion: Type 2 diabetes, aged years, born living in East or West Finl, on register to receive drug reimbursement for diabetes Exclusion: previous amputation 7 years Hospitalisation because of lower limb amputation Cox regression analysis used to investigate risk factors for amputation. Variables associated with risk of lower leg amputation after adjustment for age sex were: retinopathy (RR 3.6, 95% CI 2.2, 6.1, p<0.001), total cholesterol >6.2 mmol/l (1.8, 1.1, 3.2, p=0.047), urinary protein (1.3, 1.1, 1.6, p=0.003), fasting plasma glucose >13.4mmol/l (2.5, 1.5, 4.3, p<0.001), HbA1c >10.7% (2.4, 1.4, 4.0, p=0.001), duration of diabetes >9 years (2.2, 1.3, 3.6, p=0.004), absence of two or more peripheral artery pulses (3.9, 2.3, 6.8, p<0.001), femoral artery bruit on ascultation (2.1, 1.1, 4.0, p=0.022), bilateral absence of Achilles tendon reflexes (4.3, 2.5, 7.3, p<0.001), bilateral absence of vibration sense (2.7, 1.6, 4.7, p<0.001). Poor glycemic control is an important predictor for amputation in patients with Type 2 diabetes in addition to detectable peripheral arterial disease peripheral neuropathy. 126 Clinical Guidelines for Type 2 Diabetes