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
Secondary identifying numbers	N0436130647

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

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
Email	r&d@leedsth.nhs.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 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	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 study start date	01/09/2003
Completion date	01/03/2004

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	38 (added 06/10/09)
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

England
United Kingdom

Study participating centre

Foot Health Department, B Floor

Leeds
LS1 3EX
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

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

Funders

Funder type

Hospital/treatment centre

Leeds Teaching Hospitals NHS Trust (UK)

No information available

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	01/02/2005		Yes	No