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Patient-centred outcomes of a rheumatology podiatry service for people with foot-specific symptoms: a randomised feasibility trial

Patient-centred outcomes of a rheumatology podiatry service for people with foot-specific symptoms: a randomised feasibility trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625001000493
Enrollment
30
Registered
2025-09-09
Start date
2025-09-15
Completion date
2026-05-01
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to tackle a big problem in Australia's rheumatology healthcare system. Even though national guidelines and experts emphasise the importance of having a team of specialists, including podiatrists (foot care experts), podiatry services are missing in public rheumatology clinics. This is a major issue because foot problems are common and very painful for people with rheumatological conditions. Our proposed trial aims to show if it is worthwhile conducting a larger trial about whether adding a specialised podiatry service in rheumatology clinics can work and make a positive difference for people with foot problems due to rheumatological conditions.

Interventions

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

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”.

Sponsors

La Trobe University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026