Status:
TERMINATED
Safety and Efficacy of Delayed Manipulation After Xiaflex Treatment in Subjects With Dupuytren's Contracture
Lead Sponsor:
Indiana Hand to Shoulder Center
Collaborating Sponsors:
Stony Brook University
Conditions:
Dupuytren's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine if of manipulation of digits following collagenase injection for treatment of Dupuytren's contracture is effected by the amount of time between injection and ...
Detailed Description
Patients with Metacarpophalangeal joint contractures caused by Dupuytren's disease will be evaluated as to the timing of the finger manipulation procedure that is performed following collagenase injec...
Eligibility Criteria
Inclusion
- Adult subjects (\> 18 years) of either gender with an metacarpophalangeal joint contracture and a palpable cord of \> 20 degrees of a digit (excluding the thumb) due to Dupuytren's contracture
Exclusion
- Any subject who has had prior surgical, percutaneous needle aponeurotomy or Xiaflex treatment for Dupuytren's contracture.
- 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).
- 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 :
December 1 2012
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01226121
Start Date
December 1 2010
End Date
December 1 2012
Last Update
June 16 2014
Active Locations (2)
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1
Indiana Hand to Shoulder Center
Indianaplis, Indiana, United States, 46260
2
Stony Brook University
Stony Brook, New York, United States, 11794