The CARROT trial: CAllus Reduction Reinforcing Orthotic Therapy
Completed
- Conditions
- Rheumatoid arthritisMusculoskeletal Diseases
- Registration Number
- ISRCTN05190231
- Lead Sponsor
- eeds Teaching Hospital NHS Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 64
Inclusion Criteria
1. Positive diagnosis of RA (American Rheumatology Association [ARA]/American College of Rheumatology [ACR] classification 1987)
2. One or more painful forefoot plantar callosities (including corns)
3. Willingness to participate in trial for 18 months
4. Participants aged more than or equal to 16, male and female
Exclusion Criteria
1. Co-morbidity which would place the patient at risk if randomised to the control arm, e.g. diabetes mellitus, peripheral arterial insufficiency, loss of protective sensation, existing risk/presence of ulceration/extravasation at baseline
2. History of routine podiatric intervention including callus debridement on two or more occasions in the previous 12 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Forefoot pain measured by 100 mm Visual Analogue Scale (VAS) and the pain subscale of the Foot Function Index (FFI). Patients in both treatment arms will complete pain scores at 6, 12 and 18 weeks (± 2 weeks); and at 6, 9, 12 and 18 months (± 1 month). The Leeds Foot Impact Scale (LFIS) will be used to measure the impact of foot pain, impairment, activity limitation and footwear at baseline, 6 and 12 months and at exit (18 months).
- Secondary Outcome Measures
Name Time Method 1. Intra-operative haemorrhage, measured at 6, 12 and 18 weeks (± 2 weeks) and at 6, 9, 12 and 18 months (± 1 month)<br>2. Post-treatment infection and ulceration rates, measured at 6, 12 and 18 weeks (± 2 weeks) and at 6, 9, 12 and 18 months (± 1 month)<br>3. Number of clinical appointments required, measured at 6, 12 and 18 weeks (± 2 weeks) and at 6, 9, 12 and 18 months (± 1 month) <br>4. Temporal and spacial parameters of gait (measured at baseline and exit visit only) and forefoot plantar pressures, measured at 6, 12 and 18 weeks (± 2 weeks) and at 6, 9, 12 and 18 months (± 1 month)