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

Phase 4

Terminated

• Conditions: Dupuytren's Disease
• Interventions: Biological: Clostridial collagenase injectable

• Registration Number: NCT01226121
• Lead Sponsor: Indiana Hand to Shoulder Center

Brief Summary

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

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,

Study Timeline

• Study First Submitted: 2010-10-20
• Study First Submitted QC: 2010-10-20
• Study First Posted: 2010-10-21
• Study Start: 2010-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Results First Submitted: 2014-04-21
• Status Verified: 2014-05
• Results First Submitted QC: 2014-05-16
• Last Update Submitted: 2014-05-16
• Results First Posted: 2014-06-16
• Last Update Posted: 2014-06-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Day 1 manipulation	Clostridial collagenase injectable	Finger manipulation one day following Clostridial collagenase injectable
Day 2 manipulation	Clostridial collagenase injectable	Finger manipulation two days following Clostridial collagenase injectable
Day 4 manipulation	Clostridial collagenase injectable	Finger manipulation four days following Clostridial collagenase injectable

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Clinical Improvement (> 50% Reduction in Contracture)	30 days after injection

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients Obtaining Clinical Success at 90 Days (<=5 Degree Residual Contracture)	90 days

Trial Locations

Locations (2)

Indiana Hand to Shoulder Center; 🇺🇸 Indianaplis, Indiana, United States

Stony Brook University; 🇺🇸 Stony Brook, New York, United States