Status:
COMPLETED
MRI Results in Dupuytren's Contracture Before and After Injection With Xiaflex
Lead Sponsor:
Hospital for Special Surgery, New York
Collaborating Sponsors:
Auxilium Pharmaceuticals, Inc.
Conditions:
Dupuytren's Disease
Eligibility:
All Genders
35+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine the effects of XIAFLEX on your finger through MRI.
Detailed Description
Collagenase injections for the treatment of Dupuytren's Contracture is a newly approved protocol which has shown early efficacy. There are very few studies which examine the MRI appearance of Dupuytre...
Eligibility Criteria
Inclusion
- Subject has a diagnosis of Dupuytren's Disease affecting only the metacarpophalangeal joint of the 4th or 5th finger.
- Subject has only one finger affected by the disease.
- Patients will be 35 years of age of older.
- Patients will be able to read, speak, and understand English or have available adequate translation assistance and be able to provide voluntary written consent to participate.
Exclusion
- Female patients who are nursing or pregnant, or plan to become pregnant during the treatment phase.
- Patient has a chronic muscular, neurological or neuromuscular disorder that affects the hands.
- Patient has known allergy to collagenase or any other excipient of Xiaflex.
- Patient has received any collagenase treatments before the first dose of Xiaflex.
- Patient with abnormal coagulation, including patients who have received anticoagulant medications other than low-dose aspirin within 7 days of the injection.
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01450397
Start Date
March 1 2011
End Date
February 1 2012
Last Update
April 17 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hosptial for Special Surgery
New York, New York, United States, 10021