Title
Safety and Efficacy of Delayed Manipulation After Xiaflex Treatment in Subjects With Dupuytren's Contracture
A Post Market, Open-Label Study of the Safety and Efficacy of Delayed Manipulation After Xiaflex Treatment in Subjects With Dupuytren's Contracture
Phase
Phase 4Lead Sponsor
Indiana Hand to Shoulder CenterStudy Type
InterventionalStatus
Terminated Results PostedIndication/Condition
Dupuytren's DiseaseIntervention/Treatment
collagenase clostridium histolyticum ...Study Participants
37The purpose of this study is to determine if of manipulation of digits following collagenase injection for treatment of Dupuytren's contracture is effected by the amount of time between injection and manipulation.
Patients with Metacarpophalangeal joint contractures caused by Dupuytren's disease will be evaluated as to the timing of the finger manipulation procedure that is performed following collagenase injection. Three groups will be evaluated: group 1 will have the manipulation procedure on the day following collagenase injection, group 2 will have the manipulation procedure on the second day following collagenase injection,and group 3 will have the manipulation procedure on the fourth day following collagenase injection,
Finger manipulation performed 1, 2, or 4 days following collagenase injection
Finger manipulation one day following Clostridial collagenase injectable
Finger manipulation two days following Clostridial collagenase injectable
Finger manipulation four days following Clostridial collagenase injectable
Inclusion Criteria: Adult subjects (> 18 years) of either gender with an metacarpophalangeal joint contracture and a palpable cord of > 20 degrees of a digit (excluding the thumb) due to Dupuytren's contracture Exclusion Criteria: Any subject who has had prior surgical, percutaneous needle aponeurotomy or Xiaflex treatment for Dupuytren's contracture. 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). Any subject who cannot conform to the study visit schedule
| Event Type | Organ System | Event Term | Day 1 Manipulation | Day 2 Manipulation | Day 4 Manipulation |
|---|
