Condition category
Musculoskeletal Diseases
Date applied
11/08/2010
Date assigned
11/08/2010
Last edited
28/08/2014
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

Mr Liaquat Suleman-Verjee

ORCID ID

Contact details

Imperial College London
Kennedy Institute of Rheumatology Division
65 Aspenlea Road
London
W6 8LH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

6585

Study information

Scientific title

Acronym

Pathophysiology of Dupuytren's Contracture

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 controlled trial

Trial setting

GP practices

Trial type

Treatment

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

http://www.rcseng.ac.uk/

Funders

Funder type

Charity

Funder name

The Healing Foundation (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

Publication citations

Additional files

Editorial Notes