Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001000493
Ethics application status
Approved
Date submitted
26/08/2025
Date registered
9/09/2025
Date last updated
9/09/2025
Date data sharing statement initially provided
9/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Patient-centred outcomes of a rheumatology podiatry service for people with foot-specific symptoms: a randomised feasibility trial
Scientific title
Patient-centred outcomes of a rheumatology podiatry service for people with foot-specific symptoms: a randomised feasibility trial
Secondary ID [1] 313843 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatological condition 336490 0
Rheumatic disease 338745 0
Rheumatoid arthritis 338746 0
Foot pain 338747 0
Foot stiffness 338748 0
Dermatological conditions of the foot 338749 0
Condition category
Condition code
Inflammatory and Immune System 333003 333003 0 0
Autoimmune diseases
Musculoskeletal 333004 333004 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 335043 335043 0 0
Rheumatoid arthritis
Inflammatory and Immune System 335044 335044 0 0
Connective tissue diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive access to a free podiatry service. The podiatry service will operate from the La Trobe University Health Sciences Clinic in Melbourne, Australia. Treatment provided will be individualised to participants based on their needs and goals. Participant needs and goals will be triaged during eligibility screening, and participants will access the podiatry service as many times as they require over the 12-week duration of the trial. Based on previous research, it is anticipated that treatment will involve broad categories of:
• dermatological care (nail and callus care, education);
• musculoskeletal care (managing pain, deformity, and improve function using: (i) medication in conjunction with medical team, (ii) strengthening exercise and stretches, (iv) footwear, (v) foot orthoses, (vi) in-shoe padding, (vii) toe splints, and (viii) education);
• neurovascular care (assessment, education, management where appropriate, and referral if needed);
• foot ulcer management (pressure offloading, wound care and dressing, and referral where appropriate).

Treatment will be provided by a podiatrist with over 10 years of experience in clinical practice, who is endorsed to prescribe scheduled medicines, has undertaken further training in rheumatological conditions, and plays an active role in the Australian Rheumatology Association. For participants who require foot orthoses, Formthotics™ full length prefabricated foot orthoses will be provided. These are manufactured from a dual-density polyethylene closed cell foam that has a firm-density bottom layer (Shore-A durometer 50), and a soft-density top layer (Shore-A durometer 25). Participants will receive the foot orthoses in accordance with the manufacturer’s instructions. Participants who require footwear will be provided with a $250 discount from the cost of new footwear. The footwear will be agreed with the podiatrist and participants will be required to attend pre-arranged footwear suppliers to receive the discount. All other treatment, such as skin or nail care, exercises, or other aids, will be provided in line with standard podiatry practice in Australia.

Adherence to the interventions for the intervention group will be evaluated at weeks 6 and 12 by asking participants whether they followed the treatment plan provided by the podiatrists. Participants will be asked “Have you followed the treatment plan you were provided as part of the study?” and respond using a 5-point Likert scale from 0 meaning “Strongly disagree” to 5 “Strongly agree”.
Intervention code [1] 330424 0
Treatment: Other
Comparator / control treatment
The control group will receive usual care plus a self-management package (education and an information leaflet) based on advice from Creaky Joints Australia (29 Tips from Podiatrists for Managing Arthritis Pain in Your Feet), which provides a range of education including regular self-inspection of feet, advice about exercising to reduce foot/ankle discomfort, selecting appropriate footwear, and the use of supportive aids such as foot orthoses, ice packs, salt baths etc. For usual care, participants will be advised they can seek any treatment they prefer over the 12-week duration of the trial and their progress will be monitored. The control group will be blind to group allocation through limited disclosure. Participants will be informed that two different types of treatment are being compared, however only the intervention group will be informed about the additional access to podiatry treatment. At the conclusion of the trial, participants randomised to the control group will be invited to attend a debriefing session and will be offered the same treatment as the intervention group if the intervention is found to be effective.

For the control group, adherence will not be evaluated. Instead, participants will be asked to outline the treatment they have received for their foot symptoms during the trial period.
Control group
Active

Outcomes
Primary outcome [1] 340542 0
Participant identification and eligibility
Timepoint [1] 340542 0
After the final participant is enrolled in the trial.
Primary outcome [2] 342669 0
Recruitment
Timepoint [2] 342669 0
After final participant is enrolled in the trial
Primary outcome [3] 342670 0
Setting
Timepoint [3] 342670 0
After the final participant is enrolled in the trial
Secondary outcome [1] 444396 0
Goal attainment
Timepoint [1] 444396 0
Week 6 and 12 after enrolment
Secondary outcome [2] 451750 0
Global change
Timepoint [2] 451750 0
Week 6 and week 12 after enrolment
Secondary outcome [3] 451751 0
Foot-specific pain
Timepoint [3] 451751 0
Baseline, week 6 and week 12 after enrolment
Secondary outcome [4] 451752 0
Foot-specific pain
Timepoint [4] 451752 0
Baseline, week 6 and week 12 after enrolment
Secondary outcome [5] 451753 0
Foot-specific function
Timepoint [5] 451753 0
Baseline, week 6 and week 12 after enrolment
Secondary outcome [6] 451754 0
Foot-specific function
Timepoint [6] 451754 0
Baseline, week 6 and week 12 after enrolment
Secondary outcome [7] 451755 0
Disability
Timepoint [7] 451755 0
Baseline, week 6 and week 12 after enrolment
Secondary outcome [8] 451756 0
Stiffness
Timepoint [8] 451756 0
Baseline, week 6 and week 12 after enrolment
Secondary outcome [9] 451757 0
Fatigue
Timepoint [9] 451757 0
Baseline, week 6 and week 12 after enrolment
Secondary outcome [10] 451758 0
Change in physical activity
Timepoint [10] 451758 0
Baseline, week 6 and week 12
Secondary outcome [11] 451991 0
Intervention development
Timepoint [11] 451991 0
After the final participant completes their week 12 outcome measures.
Secondary outcome [12] 451994 0
Organisation
Timepoint [12] 451994 0
After the final participant completes the week 12 outcome measures
Secondary outcome [13] 451995 0
Flexibility of delivery
Timepoint [13] 451995 0
After the final participant completes the week 12 outcome measures
Secondary outcome [14] 451996 0
Flexibility of adherence
Timepoint [14] 451996 0
After the final participant completes the week 12 outcome measures.
Secondary outcome [15] 452001 0
Follow-up
Timepoint [15] 452001 0
After the final participant completes the week 12 outcome measures.
Secondary outcome [16] 452002 0
Primary outcome
Timepoint [16] 452002 0
Prior to trial commencement

Eligibility
Key inclusion criteria
1. be adults over 18 years of age;
2. have a diagnosis of a rheumatological condition from a rheumatologist;
3. have foot-specific symptoms rated 3/10 or greater on a numerical rating scale (e.g. pain, stiffness, dermatological complaints);
4. have experienced symptoms for at least four weeks.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. are unable to understand the English language in verbal or written form;
2. have regularly attended a podiatry service for management of their rheumatological foot problem in the past 3 months;
3. have an active bacterial infection of the foot; and
4. experience foot symptoms that are not related to the rheumatological condition.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed because the person confirming eligibility and enrolment in the trial is not involved in group allocation. Allocation will be performed by an additional investigator using the randomisation module in REDCap.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation module in REDCap will be used to randomise participants on a 1:1 ratio, using simple randomisation with stratification based on sex at birth. The allocation sequence will be generated in Stata and uploaded to REDCap.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Descriptive statistics will be used to report feasibility outcomes. Mean (SD) scores and mean differences (95% CI) will be used to explore differences in continuous variables between the groups and Cohen’s d will be calculated to evaluate efficacy for the secondary outcome measures. A small effect size (Cohen’s d > 0.20) will be regarded as an acceptable between group difference to signal efficacy. Data that is not continuous (adverse effects and use of cointerventions) will be reported using medians and interquartile ranges. Between group differences will be explored using risk ratios.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/09/2025
Actual
Date of last participant enrolment
Anticipated
1/05/2026
Actual
Date of last data collection
Anticipated
1/08/2026
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 28192 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment postcode(s) [1] 44404 0
3081 - Heidelberg West

Funding & Sponsors
Funding source category [1] 318312 0
Charities/Societies/Foundations
Name [1] 318312 0
Arthritis Australia
Country [1] 318312 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Country
Australia
Secondary sponsor category [1] 320700 0
None
Name [1] 320700 0
Address [1] 320700 0
Country [1] 320700 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316946 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 316946 0
Ethics committee country [1] 316946 0
Australia
Date submitted for ethics approval [1] 316946 0
07/03/2025
Approval date [1] 316946 0
20/05/2025
Ethics approval number [1] 316946 0
HEC25095

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

Contacts
Principal investigator
Name 139522 0
Dr Glen Whittaker
Address 139522 0
Discipline of Podiatry, La Trobe University, Melbourne campus, Victoria, Australia, 3086
Country 139522 0
Australia
Phone 139522 0
+61 394795785
Fax 139522 0
Email 139522 0
[email protected]
Contact person for public queries
Name 139523 0
Glen Whittaker
Address 139523 0
Discipline of Podiatry, La Trobe University, Melbourne campus, Victoria, Australia, 3086
Country 139523 0
Australia
Phone 139523 0
+61 394795785
Fax 139523 0
Email 139523 0
[email protected]
Contact person for scientific queries
Name 139524 0
Glen Whittaker
Address 139524 0
Discipline of Podiatry, La Trobe University, Melbourne campus, Victoria, Australia, 3086
Country 139524 0
Australia
Phone 139524 0
+61 394795785
Fax 139524 0
Email 139524 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Anyone
Conditions for requesting access:
• No requirements
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
The data will be available immediately following publication, with no end date.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Data will be shared on La Trobe University's open repository, OPAL. Please contact Dr Glen Whittaker via email ([email protected]) for queries regarding data sharing.

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.