Clinical Trial: Efficacy and Safety of Xiaflex Injection for Treatment of Dupuytren's Contracture of the Thumb

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Efficacy and Safety of Xiaflex Injections for the Treatment of Thumb Cords in Dupuytren's Contractures

Brief Summary: This study will evaluate the efficacy and safety of clostridial collagenase injections for treatment of Dupuytren's contracture of the thumb and first web space. The investigators hypothesis is that clostridial collagenase will have safety not significantly different to that demonstrated in Phase III clinical trials, and will be effective in significantly reducing the degree of thumb contracture.

Detailed Summary:
Sponsor: Indiana Hand to Shoulder Center

Current Primary Outcome: Number Patients Obtaining Clinical Improvement (>50% Reduction in Contracture) [ Time Frame: 30 days after last injection ]

Original Primary Outcome: Reduction in the primary contracture to 0-5 degrees [ Time Frame: 30 days after the last injection ]

Current Secondary Outcome:

Original Secondary Outcome: Percentage of Clinical Improvement (>50% reduction in contracture) [ Time Frame: 30 days after last injection ]

Information By: Indiana Hand to Shoulder Center

Dates:
Date Received: December 21, 2010
Date Started: December 2010
Date Completion:
Last Updated: April 8, 2015
Last Verified: April 2015