Phase II Randomized Study of Collagenase in Patients With Residual Type Dupuytren's Disease
Recruitment status was Recruiting
Evaluate the safety and efficacy of collagenase in improving flexion deformity, range of motion, and grip strength in patients with residual Dupuytren's disease.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Study Start Date:||August 1995|
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.
|United States, California|
|Stanford University Hospital||Recruiting|
|Palo Alto, California, United States, 94304|
|Contact: Vincent R Hentz 650-723-3731|
|United States, New York|
|State University of New York Health Sciences Center - Stony Brook||Recruiting|
|Stony Brook, New York, United States, 11790-7775|
|Contact: Lawrence C. Hurst 631-444-2215|
|Study Chair:||Lawrence C. Hurst||State University of New York|