Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
6585
Study information
Scientific title
Pathophysiology of Dupuytren's Contracture
Acronym
Study hypothesis
Dupuytren's disease is a common inheritable disorder, mainly affecting the hand. The digits develop progressive flexion contractures and hand function is significantly impaired. The current mainstay of treatment is surgical excision of the affected tissues but recurrence following excision is seen in approximately 40% of patients. Replacing the palmar skin with grafts obtained from a non-palmar site on the body virtually abolishes recurrence. Based on this well-established surgical observation, we have developed a novel in vitro model that replicates these interactions between skin cells and the contractile cells responsible for Dupuytren's disease. We have also identified a molecule (tenascin-C) that may control the signalling between these cell types.
Ethics approval
MREC approved, ref: 06/Q0403/95
Study design
Multicentre non-randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Surgery
Intervention
Elucidate the exact role of tenascin-C in Dupuytren's disease
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Develop candidate therapeutic target to provide non-surgical intervention to modulate the disease
Secondary outcome measures
Not provided at time of registration
Overall trial start date
02/11/2006
Overall trial end date
31/07/2011
Reason abandoned
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Planned sample size: 90
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
02/11/2006
Recruitment end date
31/07/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Imperial College London
London
W6 8LH
United Kingdom
Sponsor information
Organisation
Royal College of Surgeons of England (UK)
Sponsor details
35-43 Lincoln's Inn Fields
London
WC2A 3PE
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Healing Foundation
Alternative name(s)
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