A randomised controlled trial investigating the effect of debridement of painful and disabling forefoot plantar callosities and corns in rheumatoid arthritis.
| ISRCTN | ISRCTN74129767 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74129767 |
| Protocol serial number | N0436130647 |
| Sponsor | Department of Health |
| Funder | Leeds Teaching Hospitals NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 06/10/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Miss H J Davys
Scientific
Scientific
Foot Health Department, B Floor
Brotherton Wing
Leeds Teaching Hospitals NHS Trust
Great George Street
Leeds
LS1 3EX
United Kingdom
| Phone | +44 (0)113 3923558 |
|---|---|
| r&d@leedsth.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Primary aim: to investigate the immediate (same day) and subsequent daily effects of expert scalpel debridement of symptomatic forefoot plantar callosities and corns on forefoot pain in rheumatoid arthritis. Secondary aims: to evaluate and compare the results of plantar pressure measurement following expert scalpel debridement of forefoot symptomatic lesions in RA patients using high-resolution pressure platform and in-shoe measurement systems. To estimate associated risks (adverse reactions) of treatment including episodes of immediate discomfort post intervention, localized bleeding or ulceration at treated lesion sites. A retrospective review of forefoot pathology determined by x-ray including deformity and extent of erosions for cases where existing films are available. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Corns and collosites in rheumatoid arthritis (RA) |
| Intervention | Randomised controlled trial. Random allocation to 1. Scalpel debridement 2. Sham proceedure using blunt scalpel |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Foot pain visual analogue scales, Leeds Foot Impact Scale. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/03/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 38 |
| Key inclusion criteria | Patients with a positive diagnosis of rheumatoid arthritis (American College of Rheumatology [ACR] classification 1987) and symptomatic forefoot plantar corns and callosities. |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/09/2003 |
| Date of final enrolment | 01/03/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Foot Health Department, B Floor
Leeds
LS1 3EX
United Kingdom
LS1 3EX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2005 | Yes | No |
