ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618000994280p

Ethics application status

Submitted, not yet approved

Date submitted

23/05/2018

Date registered

14/06/2018

Date last updated

14/06/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

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

Scientific title

Effectiveness of podiatry interventions on foot ulceration and amputation in adults on dialysis: a pilot randomised controlled trial

Secondary ID [1]

None

Universal Trial Number (UTN)

None

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Foot ulceration

Amputation

End-stage renal disease

Condition category

Condition code

Renal and Urogenital

Kidney disease

Skin

Other skin conditions

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Prevention

Comparator / control treatment

Participants in the control group will NOT receive any additional (i.e. ‘experimental’) podiatry interventions, but will be entitled to their usual care. Participants in the control group that are stratified into the intermediate or high foot risk category will receive information on community podiatry options (participants in the control group will not be denied access to seeking community podiatry care during the study). All participants in the control group will receive written information on appropriate foot care and footwear.

All participants (experimental and control groups) will be encouraged to contact a member of the study team if they have any concerns during the study (e.g. discovery of new foot ulcer). If a foot ulcer (or other foot problem) is discovered by the study team in either the control group or experimental group, this will be flagged to the renal dialysis nurses/medical teams for further follow-up e.g. referral to a vascular clinic or high-risk foot clinic.

Control group

Active

Outcomes

Primary outcome [1]

Foot ulceration - participant interview, visual inspection, foot ulcer assessment form and review of medical records

Timepoint [1]