Back to resultsMRI Results in Dupuytren's Contracture Before and After Injection With Xiaflex
Primary Purpose
Dupuytren's Disease
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
XIAFLEX
Sponsored by
About this trial
This is an interventional treatment trial for Dupuytren's Disease focused on measuring Dupuytren's Contracture
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Hosptial for Special Surgery
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
XIAFLEX
Arm Description
XIAFlEX
Outcomes
Primary Outcome Measures
The Measured Change in Volume of the Cord by MRI Before and After XIAFLEX Injection and Manual Manipulation.
Change in Volume (millimeter cubed) of the Cord by MRI between Baseline and 30 days after XIAFLEX injection and manual manipulation.
Secondary Outcome Measures
Full Information
NCT ID
NCT01450397
First Posted
October 10, 2011
Last Updated
March 20, 2017
Sponsor
Hospital for Special Surgery, New York
Collaborators
Auxilium Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01450397
Brief Title
MRI Results in Dupuytren's Contracture Before and After Injection With Xiaflex
Official Title
MRI Results in Dupuytren's Contracture Before and After Injection With Xiaflex
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York
Collaborators
Auxilium Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 Dupuytren's disease. There are no studies that evaluate the condition of the cord after collagenase injection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dupuytren's Disease
Keywords
Dupuytren's Contracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
XIAFLEX
Arm Type
Other
Arm Description
XIAFlEX
Intervention Type
Biological
Intervention Name(s)
XIAFLEX
Other Intervention Name(s)
Collagenase
Intervention Description
One Injection of 0.58 mg of Xiaflex into the affected area of the hand.
Primary Outcome Measure Information:
Title
The Measured Change in Volume of the Cord by MRI Before and After XIAFLEX Injection and Manual Manipulation.
Description
Change in Volume (millimeter cubed) of the Cord by MRI between Baseline and 30 days after XIAFLEX injection and manual manipulation.
Time Frame
Baseline and 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott W Wolfe, MD
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hosptial for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Learn more about this trial
MRI Results in Dupuytren's Contracture Before and After Injection With Xiaflex
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