MRI Results in Dupuytren's Contracture Before and After Injection With Xiaflex
This study has been completed.
Auxilium Pharmaceuticals, Inc
Information provided by (Responsible Party):
Scott Wolfe, Hospital for Special Surgery, New York
First received: October 10, 2011
Last updated: March 18, 2013
Last verified: March 2013
The purpose of this study is to determine the effects of XIAFLEX on your finger through MRI.
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||MRI Results in Dupuytren's Contracture Before and After Injection With Xiaflex
Primary Outcome Measures:
- The primary outcome will be the measured volume of the cord by MRI before and after XIAFLEX injection and manual manipulation. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||January 2012 (Final data collection date for primary outcome measure)
One Injection of 0.58 mg of Xiaflex into the affected area of the hand.
Other Name: Collagenase
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 Dupuytren's disease. There are no studies that evaluate the condition of the cord after collagenase injection.
|Ages Eligible for Study:
||35 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01450397
|Hosptial for Special Surgery
|New York, New York, United States, 10021 |
Auxilium Pharmaceuticals, Inc
||Scott W Wolfe, MD
||Hospital for Special Surgery, New York
No publications provided
||Scott Wolfe, Prinicpal Investigator, Hospital for Special Surgery, New York
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 10, 2011
||March 18, 2013
||United States: Institutional Review Board
Keywords provided by Hospital for Special Surgery, New York:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 09, 2014
Connective Tissue Diseases