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Trial registered on ANZCTR


Registration number
ACTRN12618000994280
Ethics application status
Approved
Date submitted
23/05/2018
Date registered
14/06/2018
Date last updated
27/08/2024
Date data sharing statement initially provided
27/08/2024
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] 293484 0
None
Universal Trial Number (UTN)
None
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Foot ulceration 307986 0
Amputation 307987 0
End-stage renal disease 307988 0
Condition category
Condition code
Renal and Urogenital 307022 307022 0 0
Kidney disease
Skin 307023 307023 0 0
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] 301309 0
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] 306001 0
Foot ulceration - participant interview, visual inspection, foot ulcer assessment form and review of medical records
Timepoint [1] 306001 0
12 months post-intervention commencement
Primary outcome [2] 306002 0
Amputation - participant interview, visual inspection and review of medical records
Timepoint [2] 306002 0
12 months post-intervention commencement
Secondary outcome [1] 347277 0
Episodes of infection of the foot or lower limb - participant interview and review of medical records
Timepoint [1] 347277 0
12 months post-intervention commencement
Secondary outcome [2] 347278 0
Foot-related hospitalisations - participant interview and review of medical records
Timepoint [2] 347278 0
12 months post-intervention commencement
Secondary outcome [3] 347279 0
Revascularisation procedures of the lower limb - participant interview and review of medical records
Timepoint [3] 347279 0
12 months post-intervention commencement
Secondary outcome [4] 347281 0
Foot-related mortality (i.e. systemic sepsis secondary to foot ulcer infection) - review of medical records
Timepoint [4] 347281 0
12 months post-intervention commencement

Eligibility
Key inclusion criteria
Participants will be eligible if they have end-stage renal disease and are clinically stable on haemodialysis, are at least 18 years of age, and are cognitively aware.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those with a current foot ulcer or existing podiatry interventions in place will be excluded.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The investigator generating and administering the allocation sequence will not have contact with participants throughout the study. Allocation will be concealed by using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Treatment allocation will be according to a computer generated randomised number sequence for 40 allocations (approximately 20 experimental, 20 control). To prevent subversion of the allocation sequence, we will generate the sequence using uneven blocks.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
It is not possible to blind participants/investigator to the podiatry interventions used in this pilot trial.
Phase
Phase 0
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will initially be entered into an excel spreadsheet for initial organisation and manipulation. Baseline and primary/secondary outcome data will be expressed as mean ± SD or median (IQR). Continuous data will be checked for normality prior to analysing with parametric statistics. If data is not normally distributed, transformation will be attempted, and if still not normally distributed, the data will be analysed using non-parametric statistics. To explore between-group differences, independent samples t-tests, Mann-Whitney U tests and/or Chi-square tests will be used depending on data type. Statistical analyses will be completed on an intention-to-treat basis using IBM SPSS software. Statistical significance will be set at the conventional level of 0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/07/2018
Actual
18/01/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
28
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 10974 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 22763 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 298103 0
Hospital
Name [1] 298103 0
St Vincent's Hospital Melbourne (Reseach Endowment Fund)
Country [1] 298103 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Melbourne
Address
41 Victoria Parade, Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 297180 0
None
Name [1] 297180 0
Address [1] 297180 0
Country [1] 297180 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299123 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 299123 0
Ethics committee country [1] 299123 0
Australia
Date submitted for ethics approval [1] 299123 0
12/12/2017
Approval date [1] 299123 0
05/12/2018
Ethics approval number [1] 299123 0
HREC/17/SVHM/283

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79374 0
Dr Michelle Kaminski
Address 79374 0
c/o Podiatry Department, Monash Health, 246 Clayton Road, Clayton, VIC 3168
Country 79374 0
Australia
Phone 79374 0
+614 9454 2382
Fax 79374 0
None
Email 79374 0
michelle.kaminski@monashhealth.org
Contact person for public queries
Name 79375 0
Michelle Kaminski
Address 79375 0
c/o Podiatry Department, Monash Health, 246 Clayton Road, Clayton, VIC 3168
Country 79375 0
Australia
Phone 79375 0
+614 9454 2382
Fax 79375 0
+614 9231 3808
Email 79375 0
michelle.kaminski@monashhealth.org
Contact person for scientific queries
Name 79376 0
Michelle Kaminski
Address 79376 0
c/o Podiatry Department, Monash Health, 246 Clayton Road, Clayton, VIC 3168
Country 79376 0
Australia
Phone 79376 0
+614 9454 2382
Fax 79376 0
+614 9231 3808
Email 79376 0
michelle.kaminski@monashhealth.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data (IPD) collected during the trial, after de-identification.
When will data be available (start and end dates)?
Immediately following publication for 25 years and then will be destroyed.
Available to whom?
Researchers with reasonable data requests with a sound methodological proposal can be made to the corresponding author.
Available for what types of analyses?
For any purpose
How or where can data be obtained?
Datasets used and/or analysed can be obtained from the corresponding author on reasonable request.
Access to data sets are subject to approval by the Principal Investigator (michelle.kaminski@monashhealth.org or m.kaminski@latrobe.edu.au).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23582Study protocolKaminski MR, Raspovic A, McMahon LP, Erbas B, Landorf KB. Risk factors for foot ulceration in adults with end-stage renal disease on dialysis: study protocol for a prospective observational cohort study. J Foot Ankle Res. 2015;8:53.  



Results publications and other study-related documents

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