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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-12-31

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.

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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,

Conditions

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Dupuytren's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Day 1 manipulation

Finger manipulation one day following Clostridial collagenase injectable

Group Type ACTIVE_COMPARATOR

Clostridial collagenase injectable

Intervention Type BIOLOGICAL

Finger manipulation performed 1, 2, or 4 days following collagenase injection

Day 2 manipulation

Finger manipulation two days following Clostridial collagenase injectable

Group Type ACTIVE_COMPARATOR

Clostridial collagenase injectable

Intervention Type BIOLOGICAL

Finger manipulation performed 1, 2, or 4 days following collagenase injection

Day 4 manipulation

Finger manipulation four days following Clostridial collagenase injectable

Group Type ACTIVE_COMPARATOR

Clostridial collagenase injectable

Intervention Type BIOLOGICAL

Finger manipulation performed 1, 2, or 4 days following collagenase injection

Interventions

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Clostridial collagenase injectable

Finger manipulation performed 1, 2, or 4 days following collagenase injection

Intervention Type BIOLOGICAL

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes