Dupytren’s disease studyA randomized controlled study comparing enzyme treatment (with clostridium histolyticum) with needle transection of Dupytren’s finger contracture.

Conditions: Dupytren’s disease, primary MCP joint contractures of the third, forth and fifth finger of the hand.
MedDRA version: 14.1Level: LLTClassification code 10009904Term: Collagen disorder NOSSystem Organ Class: 100000004859
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

Registration Number: EUCTR2013-001221-13-NO

Lead Sponsor: Akershus university hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

•30 ° or more contracture of one MCP-joint (3. -5. Finger)
•Less than 20 ° contracture of adjacent PIP joint
•Single hand involvement
•Primary contracture (not operated or treated hand earlier for this condition)
•Patients 18 years or older.

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 40

Exclusion Criteria

•Patients with under 30 ° MCP joint contracture or
•20 ° or more contracture of the adjacent PIP
•Ongoing treatment with platelet inhibitors
•Prior treatment with tetracycline, 2 weeks earlier to treatment
•Patients who are pregnant
•Patients with known allergic reaction to local anesthetic or Clostridium Histolyticum
•Patients that have been treated for Dupuytren´s earlier on involved hand
•Involvement with need to treat” of both hands