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ISRCTN
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ISRCTN74129767
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ClinicalTrials.gov identifier
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Public title
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A randomised controlled trial investigating the effect of debridement of painful and disabling forefoot plantar callosities and corns in rheumatoid arthritis.
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0436130647
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Corns and collosites in rheumatoid arthritis (RA)
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Participants - inclusion criteria
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Patients with a positive diagnosis of rheumatoid arthritis (American College of Rheumatology [ACR] classification 1987) and symptomatic forefoot plantar corns and callosities.
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Participants - exclusion criteria
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Does not match inclusion criteria
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Anticipated start date
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01/09/2003
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Anticipated end date
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01/03/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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38 (added 06/10/09)
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Interventions
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Randomised controlled trial. Random allocation to
1. Scalpel debridement
2. Sham proceedure using blunt scalpel
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Leeds Teaching Hospitals NHS Trust (UK)
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Trial website
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Publications
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2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15479752
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Contact name
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Miss
H J
Davys
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Address
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Foot Health Department, B Floor
Brotherton Wing
Leeds Teaching Hospitals NHS Trust
Great George Street
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City/town
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Leeds
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Zip/Postcode
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LS1 3EX
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Country
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United Kingdom
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Tel
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+44 (0)113 3923558
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Fax
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+44 (0)113 242 6496
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Email
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r&d@leedsth.nhs.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
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Address
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The Department of Health,
Richmond House,
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2004
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Last edited
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06/10/2009
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Date ISRCTN assigned
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30/09/2004
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