Efficacy and Safety of Xiaflex Injection for Treatment of Dupuytren's Contracture of the Thumb

Phase 4

Completed

• Conditions: Dupuytren's Contracture
• Interventions: Biological: Injectable clostridial collagenase

• Registration Number: NCT01265420
• Lead Sponsor: Indiana Hand to Shoulder Center

Brief Summary

This 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-21
• Study First Submitted QC: 2010-12-22
• Study First Posted: 2010-12-23
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Results First Submitted: 2015-03-28
• Results First Submitted QC: 2015-03-28
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-08
• Results First Posted: 2015-04-09
• Last Update Posted: 2015-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Injectable clostridial collagenase	Injectable clostridial collagenase	Patients with thumb 1st web contracture secondary to Dupuytren's disease will be treated with 0.58mg of collagenase

Primary Outcome Measures

Name	Time	Method
Number Patients Obtaining Clinical Improvement (>50% Reduction in Contracture)	30 days after last injection

Trial Locations

Locations (1)

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