The efficacy of CCH in the thumb and first webspace in Dupuytren's Disease.
- Conditions
- Dupuytren'Disease, thumb, first webspace, collagenase (Xiapex) injectionsZiekte van Dupuytren, duim, eerste webspace, collagenase injecties
- Registration Number
- NL-OMON27401
- Lead Sponsor
- Prof P.M.N.WerkerP.O.Box 300019700RB Groningen+31503618840p.m.n.werker@umcg.nl
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 15
Inclusion Criteria
1. At least 18 years of age and ≤ 75 years;
2. Presenting with a Dupuytren’s contracture at MCPJ of thumb of at least 20° caused by a palpable cord, or any adduction contracture of the thumb with palpable cords in first web space;
Exclusion Criteria
1. Nursing or pregnant, or planning to become pregnant during the treatment phase;
2. On an investigational drug within 30 days prior to the first dose of CCH;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in extension deficit to 0-5 degrees 30 days after last injection.
- Secondary Outcome Measures
Name Time Method 1. Goniometry and pollexography will be used to measure baseline and 1, 7, 30 and 90 days and 6 months after last injection for mean change in range of motion from baseline - degrees;<br /><br>2. Change in Patient and physician global assessment of treatment satisfaction” from baseline and 7, 30 and 90 days and 6 months after injection, whereby investigator and patient will complete a brief set of questions;<br /><br>3. Change in outcome of PRWHE DLV (Patient rated wrist/hand evaluation Dutch language version (37)) from baseline and 7, 30 and 90 days and 6 months after injection whereby the patient will fill in the questionnaire;<br /><br>4. Photographs will be taken of the diseased hand, during screening and at 30 and 90 days and 6 months.