RheumAFooT (Rheumatoid Arthritis Foot Trial)
| ISRCTN | ISRCTN01982076 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN01982076 |
| Secondary identifying numbers | G108/397 |
- Submission date
- 14/08/2003
- Registration date
- 18/08/2003
- Last edited
- 22/11/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr James Woodburn
Scientific
Scientific
Academic Unit of Musculoskeletal Disease
School of Medicine
University of Leeds
Leeds
LS2 9NZ
United Kingdom
| Phone | +44 (0)113 343 4938 |
|---|---|
| j.woodburn@leeds.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | RheumAFooT |
| Study objectives | The aim of this trial is to compare podiatry with no podiatry footcare in rheumatoid arthritis (RA) patients with painful and disabling foot symptoms. The objectives are: Primary objective: To compare foot health status (activities, impairment, participation and shoe) between active and control groups using the Leeds Foot Impact Scale. Secondary objective 1: To compare foot function (spatial and temporal gait parameters) between the two groups using instrumented gait analysis. Secondary objective 2: To test whether the effect of podiatry, as measured by Leeds Foot Impact Scale, is correlated with patient sex, disease duration and degree of initial foot health status. Secondary objective 3: To determine the cost effectiveness of podiatry care for RA related foot problems. |
| Ethics approval(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | Rheumatoid arthritis |
| Intervention | Active treatment arm: 12 months podiatry care Control treatment arm: 12 months |
| Intervention type | Other |
| Primary outcome measure | Primary outcome: change in Leeds Foot Impact Scale score between baseline and 12 months. |
| Secondary outcome measures | Disease activity score, health assessment questionnaire and walking speed were also recorded. |
| Overall study start date | 01/10/2003 |
| Completion date | 30/09/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 34 |
| Key inclusion criteria | Patients will be suitable for inclusion if they have a definite diagnosis of RA (satisfying the 1987 American Rheumatism Association revised criteria for RA), are between 18-80 years of age and can read and write English. Patients must also have a current history of foot impairment as determined by standard history and clinical examination techniques and a Leeds Foot Impact Scale score of ≥15 points. Patients must also have stable drug management in the 3 months prior to recruitment including Disease Modifying Anti-Rheumatic Drugs, Non-Steroidal Anti-Inflammatory Drugs and oral corticosteroids. |
| Key exclusion criteria | Patients will be excluded if they have foot problems related to and require treatment under the appropriate medical specialty such as diabetes and peripheral vascular disease. Patients will be excluded if they have severe complications of their RA resulting in active or high risk of developing foot ulceration. On medical consultation, any patient with foot problems, such as ulceration and infection, likely to complicate systematic treatment with biologic and other immunosuppressant therapy (Infliximab, Etanercept, Anakinra, Cyclophosphamide, Cyclosporin, Azathioprine and any new, including trial, biologic - even if placebo) will be excluded. Those patients who have received podiatry treatment at Leeds General Infirmary Foot Health Department in the last 3 months will also be excluded. |
| Date of first enrolment | 01/10/2003 |
| Date of final enrolment | 30/09/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Academic Unit of Musculoskeletal Disease
Leeds
LS2 9NZ
United Kingdom
LS2 9NZ
United Kingdom
Sponsor information
Medical Research Council (UK)
Government
Government
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7670 5259 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk |
Funders
Funder type
Government
Medical Research Council (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 06/11/2007 | Yes | No |
