Condition category
Musculoskeletal Diseases
Date applied
14/08/2003
Date assigned
18/08/2003
Last edited
22/11/2007
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr James Woodburn

ORCID ID

Contact details

Academic Unit of Musculoskeletal Disease
School of Medicine
University of Leeds
Leeds
LS2 9NZ
United Kingdom
+44 (0)113 343 4938
j.woodburn@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G108/397

Study information

Scientific title

Acronym

RheumAFooT

Study hypothesis

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

Not provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Rheumatoid arthritis

Intervention

Active treatment arm: 12 months podiatry care
Control treatment arm: 12 months

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/10/2003

Overall trial end date

30/09/2005

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

34

Participant 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.

Recruitment start date

01/10/2003

Recruitment end date

30/09/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Unit of Musculoskeletal Disease
Leeds
LS2 9NZ
United Kingdom

Sponsor information

Organisation

Medical Research Council (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7670 5259
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in: http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17986338&ordinalpos=3&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum

Publication citations

  1. Results

    Turner DE, Helliwell PS, Woodburn J, Methodological considerations for a randomised controlled trial of podiatry care in rheumatoid arthritis: lessons from an exploratory trial., BMC Musculoskelet Disord, 2007, 8, 109, doi: 10.1186/1471-2474-8-109.

Additional files

Editorial Notes