Safety and Efficacy of Delayed Manipulation After Xiaflex Treatment in Subjects With Dupuytren's Contracture

Study Overview
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Brief Summary
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The 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.

Detailed Description
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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,

Official Title
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A Post Market, Open-Label Study of the Safety and Efficacy of Delayed Manipulation After Xiaflex Treatment in Subjects With Dupuytren's Contracture

Conditions
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Dupuytren's Disease

Intervention / Treatment
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* Biological: Clostridial collagenase injectable


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Day 1 manipulation<br>Finger manipulation one day following Clostridial collagenase injectable | Biological: Clostridial collagenase injectable<br>* Finger manipulation performed 1, 2, or 4 days following collagenase injection<br>|
| Active Comparator: Day 2 manipulation<br>Finger manipulation two days following Clostridial collagenase injectable | Biological: Clostridial collagenase injectable<br>* Finger manipulation performed 1, 2, or 4 days following collagenase injection<br>|
| Active Comparator: Day 4 manipulation<br>Finger manipulation four days following Clostridial collagenase injectable | Biological: Clostridial collagenase injectable<br>* Finger manipulation performed 1, 2, or 4 days following collagenase injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With Clinical Improvement (> 50% Reduction in Contracture) |  | 30 days after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients Obtaining Clinical Success at 90 Days (<=5 Degree Residual Contracture) |  | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dupuytren, dupuytren's