Effect of podiatry intervention on foot ulceration and amputations in adults on dialysis

PART 1: OVERVIEW All participants will be randomly allocated to one of two groups that will receive: (i) podiatry intervention (experimental group), or (ii) usual care (control group). Data collection for all participants will occur during their routine haemodialysis treatment sessions, so additional visits will not be required. All data will be determined based on an interview with the participant, completion of 3 questionnaires, reviewing the participant’s hospital medical record (the participant’s blood test results will be accessed from the standard tests conducted by the renal unit), and by conducting a non-invasive foot assessment. Medical records will be referred to for confirmation of medical history, blood test results and where applicable, dates where e.g. foot ulceration was detected. Participants will be required to attend 2-3 face-to-face appointments for data collection: (i) a baseline appointment (approximately 2 hours), (ii) a 6-month appointment if participant is found to be at intermediate/high risk of foot problems or allocated to experimental group (approximately 1.5 hours), and (iii) a 12 month follow-up appointment (approximately 1.5 hours). The Chief Investigator will be responsible for the collection of data at these appointments. PART 2: PRIMARY AND SECONDARY OUTCOMES The primary outcomes are the development of a new foot ulcer or new lower limb amputation. The secondary outcomes include: number of foot ulcers/amputations, episodes of infection of the foot or lower limb, foot-related hospitalisations, revascularisation procedures of the lower limb, and foot-related mortality. PART 3: BASELINE APPOINTMENT The baseline appointment will take approximately two hours to complete (interview - 15-20 minutes, 3x questionnaires - 20-30 minutes, foot assessment - 60 minutes). 3.1 Participant interview/review of medical history 1) Demographic/characteristics/socio-economic data Age, gender, height, weight, body mass index, current/past smoking history, living arrangements (i.e. living alone). 2) Medical history data Cause of end-stage renal disease, dialysis duration, co-morbidities 3) Laboratory results (routine blood tests) data 4) History of foot complications Foot ulceration, amputation 3.2 Questionnaires All participants will be asked to complete 3 questionnaires: (i) perceptions of risk for foot complications and barriers to foot care, (ii) Nottingham Assessment of Functional Footcare (NAFF)® [1], and (iii) generic health survey EQ-5D-5L at their baseline appointment. All participants will complete the NAFF® and EQ-5D-5L questionnaires again at the 12-month follow-up appointment to review the effectiveness of the foot care education provided and if there are any changes to health-related quality of life. 3.3 Foot assessment All participants will have their feet screened for neurological, arterial, biomechanical and dermatological abnormalities. Footwear will also be assessed. At baseline, participants will be stratified into foot risk categories as per the NHMRC approved guidelines [2]: “Low risk” – people with no risk factors and no previous history of foot ulcer/amputation “Intermediate risk” – people with one risk factor (neuropathy, peripheral arterial disease or foot deformity) and no previous history of foot ulcer/amputation “High risk” – people with two or more risk factors (neuropathy, peripheral arterial disease or foot deformity) and/or a previous history of foot ulcer/amputation Details of the foot examination are outlined below: 1) Neurological assessment Vibration perception (tuning fork), protective sensation (Semmes-Weinstein 5.07/10g monofilament 2) Arterial assessment Palpation of pedal pulses, ankle-brachial pressure index, toe-brachial pressure index, systolic toe pressure, 3) Biomechanical assessment Range of motion of first metatarsophalangeal joint (goniometer), foot deformity 4) Dermatological assessment Skin and nail pathology 5) Footwear assessment Fit, type, condition and general features PART 4: INTERVENTIONS Allocated podiatry interventions will be provided to the experimental group by qualified podiatrists with a minimum of 5 years' experience and will be delivered in a face-to-face manner. These interventions will be undertaken in the satellite haemodialysis units or the outpatient podiatry department, depending on the participant’s preference. The podiatry interventions (i.e. for the experimental group) will commence after the initial baseline appointment. The interventions are all commonly used in podiatric practice and are low risk of harm. All participants randomly allocated to the experimental group will receive ALL of the following podiatry interventions: 1) Foot examination at baseline, 6-months and 12 months; 2) Podiatry review and foot care (which includes nail cutting and reduction of skin lesions e.g. calluses/corns) every 8-10 weeks within the haemodialysis unit or can alternatively attend the outpatient podiatry clinic (depending on participant preference for location of podiatry treatment); 3) One-on-one tailored education on appropriate foot care and footwear by a qualified podiatrist. Education will be based on the resource developed by Diabetes Australia entitled 'My feet and diabetes - a pictorial guide'; 4) Written information on appropriate foot care and footwear from the Diabetes Australia resource 'My feet and diabetes - a pictorial guide' will be provided, same as control group) and; 4) Footwear assessment and recommendations will be provided. All of the podiatry interventions outlined above will start following the baseline appointment and will end following the 12-month follow-up appointment. PART 5: ADHERENCE TO INTERVENTION As participants will be seen by qualified podiatrists during their usual haemodialysis treatment sessions for their baseline, 6-month and 12-month foot examinations and their podiatry review and foot care appointments, adherence to the podiatry interventions is likely to be high. With regard to the foot care and footwear education provided, adherence will be monitored using the Nottingham Assessment of Functional Footcare (NAFF)® questionnaire (this will be completed at baseline and 12-months). PART 6: REFERENCES 1. Lincoln NB, Jeffcoate WJ, Ince P, Smith M, Radford KA. Validation of a new measure of protective footcare behaviour: the Nottingham Assessment of Functional Footcare (NAFF). Prac Diab Int. 2007;24:207-211. 2. Baker IDI Heart and Diabetes Institute, The George Institute for Global Health, Adelaide Health Technology Assessment. Prevention, identification and management of foot complications in diabetes (Evidence-Based Clinical Summary). Baker IDI Heart & Diabetes Institute, 2011. Melbourne, Australia.