Treatment of Dupuytrens contracture in metacarpophalangeal joints by needle treatment vs injection with collagenase enzyme.

Phase 1

• Conditions: Dupuytrens contracture; MedDRA version: 16.0 Level: LLT Classification code 10065799 Term: Fibrosis deep connective tissue System Organ Class: 100000004859; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2013-000494-67-DK
• Lead Sponsor: Klinik for håndkirurgi, Gentofte hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-09
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 90

Inclusion Criteria

1) Dupuytrens disease with one cord in the hand pointing at 2nd, 3rd, 4th or 5th finger.
2) Lag of extension im metacarpophalangeal joint of at least 30 degrees.
3) age > 18 years
4) women and men
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1) Former treatment of Dupuytrens disease in the same hand.
2) Other signs of dupuytrens disease than a single cord.
3) lag of extension in proximal- and distal interphalangeal joint in the affected finger.
4) Other dibiliating disease in the affected hand.
5) Allergi or intollerance of collagenase enzyme
6) pregnant women
7) patient that cannot attend follow up
8) anticoagulant medicin other than ASA 150 mg daily
9) treatment with tetracyclin or ciprofloxacin within 2 weeks.

Study & Design

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