Loading clinical trials...
Loading clinical trials...
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.
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
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Stanford University Hospital
Palo Alto, California, United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, United States
Start Date
August 1, 1995
Completion Date
April 1, 2004
Last Updated
March 25, 2015
36
ESTIMATED participants
collagenase
DRUG
Lead Sponsor
State University of New York
NCT05877066
NCT04607187
NCT01588353
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions