Status:
COMPLETED
Efficacy and Safety of Xiaflex Injection for Treatment of Dupuytren's Contracture of the Thumb
Lead Sponsor:
Indiana Hand to Shoulder Center
Conditions:
Dupuytren's Contracture
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study will evaluate the efficacy and safety of clostridial collagenase injections for treatment of Dupuytren's contracture of the thumb and first web space. The investigators hypothesis is that c...
Eligibility Criteria
Inclusion
- Adult subjects (\> 18 years) of either gender with an MP and/or IP joint contracture and a palpable cord of \> 20 degrees of the thumb
- First web space contracture with a palpable cord due to Dupuytren's contracture
Exclusion
- Prior surgical, percutaneous needle aponeurotomy or Xiaflex treatment for Dupuytren's contracture of the same thumb.
- Any subject using anti-coagulant therapy other than low dose aspirin (up to 150mg/day).
- Any subject in the opinion of the MD investigators with chronic, severe or terminal medical illness which would make them unsuitable for study participation.
- Any subject with known allergy to Xiaflex (Clostridial collagenase).
- Pregnant or nursing female
- Any subject who cannot conform to the study visit schedule
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01265420
Start Date
December 1 2010
End Date
February 1 2014
Last Update
April 30 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Indiana Hand to Shoulder Center
Indianaplis, Indiana, United States, 46260