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

Completed · Phase 4

Conditions studied: Dupuytren's Contracture

In brief

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.

Key facts

Study ID

NCT01265420

Run by

Indiana Hand to Shoulder Center

People needed

7

Starts

2010-12-01

Expected to finish

2014-02-01

Last updated by the study team

2015-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Indiana Hand to Shoulder Center — Indianaplis, Indiana, United States

Full record on ClinicalTrials.gov

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