Phase II Randomized Study of Collagenase in Patients With Residual Type Dupuytren's Disease
- Conditions
- Dupuytren's Contracture
- Registration Number
- NCT00004409
- Lead Sponsor
- State University of New York
- Brief Summary
OBJECTIVES:
Evaluate the safety and efficacy of collagenase in improving flexion deformity, range of motion, and grip strength in patients with residual Dupuytren's disease.
- Detailed Description
PROTOCOL OUTLINE: This is a randomized, investigator-blinded, placebo-controlled study.
Patients receive a single dose of either collagenase or placebo into the target finger on day 0. Patients who do not respond at the 1 month follow up visit may receive an injection of open label collagenase, if IgE antibody levels are no greater than 15 ng/mL.
Following treatment, patients use a nighttime extension splint for 4 months and perform finger flexion/extension exercises. Patients are followed at 1, 7, and 14 days, and at 1, 2, 3, 6, 9, and 12 months, for each joint treated.
Completion date provided represents the completion date of the grant per OOPD records
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Stanford University Hospital
🇺🇸Palo Alto, California, United States
State University of New York Health Sciences Center - Stony Brook
🇺🇸Stony Brook, New York, United States