Title
Efficacy and Safety of Xiaflex Injection for Treatment of Dupuytren's Contracture of the Thumb
The Efficacy and Safety of Xiaflex Injections for the Treatment of Thumb Cords in Dupuytren's Contractures
Phase
Phase 4Lead Sponsor
Indiana Hand to Shoulder CenterStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Dupuytren's ContractureIntervention/Treatment
collagenase clostridium histolyticum ...Study Participants
7This 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.
Injection of 0.58mg clostridial collagenase into Dupuytren's cord, up to three injections
Patients with thumb 1st web contracture secondary to Dupuytren's disease will be treated with 0.58mg of collagenase
Inclusion Criteria: Adult subjects (> 18 years) of either gender with an MP and/or IP joint contracture and a palpable cord of > 20 degrees of the thumb First web space contracture with a palpable cord due to Dupuytren's contracture Exclusion Criteria: Prior surgical, percutaneous needle aponeurotomy or Xiaflex treatment for Dupuytren's contracture of the same thumb. Any subject using anti-coagulant therapy other than low dose aspirin (up to 150mg/day). Any subject in the opinion of the MD investigators with chronic, severe or terminal medical illness which would make them unsuitable for study participation. Any subject with known allergy to Xiaflex (Clostridial collagenase). Pregnant or nursing female Any subject who cannot conform to the study visit schedule
| Event Type | Organ System | Event Term | Injectable Clostridial Collagenase |
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