Is collagenase injection as effective as surgery for the treatment of moderate Dupuytren’s Contracture in adult patients?

Phase 1

• Conditions: Dupuytren's contracture; MedDRA version: 19.1Level: PTClassification code 10013873Term: Dupuytren's contracture operationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]; MedDRA version: 19.1Level: PTClassification code 10013872Term: Dupuytren's contractureSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

• Registration Number: EUCTR2016-004251-76-GB
• Lead Sponsor: niversity Hospitals of Leicester NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-30
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 710

Inclusion Criteria

• Male or Female and aged 18 years or over
• Presence of discrete, palpable, contracted cord involving the metacarpophalangeal joint and/or proximal interphalangeal joint of a finger
• Degree of contracture >30 degrees in either joint i.e. patient cannot put the palm of the hand flat on a table (Hueston’s Tabletop test)
• Able to identify a predominant finger for treatment which would not require more than one collagenase injection as treatment for a single cord
• Appropriate for limited fasciectomy and collagenase injection for Dupuytren’s contracture (i.e. not requiring skin grafting or PNF (eg discrete MCP cords in elderly))
• Patient is willing and able to give informed consent for participation in the study.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 639
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 71

Exclusion Criteria

• Severe contractures of both metacarpophalangeal joint and/or proximal interphalangeal joints (Tubiana Grade 4)
• History of previous intervention for Dupuytren’s contracture (e.g. limited fasciectomy, collagenase injection or needle fasciectomy) on the same hand
• History of any other pre-existing disorder of the hand causing restriction of movement and/or pain and affecting hand function e.g. post traumatic stiffness, stiffness due to other causes, infection, arthritis
• Non-English speaking because of the need to complete multiple questionnaires which have not been validated in multiple languages
• Resident in a location where attendance for follow up at one of the study recruiting centres will not be possible
• Contraindicated for use of Collagenase
• Any other significant disease or disorder (including autoimmune disorders) which, in the opinion of the Investigator, may put the participant at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study.
• Participants who have participated in another research study involving an investigational product in the past 12 weeks
• Female participants who are pregnant or breastfeeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified