Condition category
Skin and Connective Tissue Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
06/10/2009
Prospective/Retrospective
Retrospectively 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

Miss H J Davys

ORCID ID

Contact details

Foot Health Department
B Floor
Brotherton Wing
Leeds Teaching Hospitals NHS Trust
Great George Street
Leeds
LS1 3EX
United Kingdom
+44 (0)113 3923558
r&d@leedsth.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436130647

Study information

Scientific title

Acronym

Study hypothesis

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

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

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

Phase

Not Specified

Drug names

Primary outcome measures

1. Foot pain visual analogue scales, Leeds Foot Impact Scale.
2. Spatial & temporal parameters using GaitRite system
3. Plantar pressure measurement using Novel Pedar in-shoe system an emed-sf platform.
4. Individual Larsen score for each metatarsophalangeal (MTP) joint.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2003

Overall trial end date

01/03/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with a positive diagnosis of rheumatoid arthritis (American College of Rheumatology [ACR] classification 1987) and symptomatic forefoot plantar corns and callosities.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

38 (added 06/10/09)

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/09/2003

Recruitment end date

01/03/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Foot Health Department, B Floor
Leeds
LS1 3EX
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

Leeds Teaching Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15479752

Publication citations

  1. Results

    Davys HJ, Turner DE, Helliwell PS, Conaghan PG, Emery P, Woodburn J, Debridement of plantar callosities in rheumatoid arthritis: a randomized controlled trial., Rheumatology (Oxford), 2005, 44, 2, 207-210, doi: 10.1093/rheumatology/keh435.

Additional files

Editorial Notes