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

Indiana Hand to Shoulder Center

Status and phase

Completed

Phase 4

Conditions

Dupuytren's Contracture

Treatments

Biological: Injectable clostridial collagenase

Study type

Interventional

Funder types

Other

Identifiers

NCT01265420

IHtSC-Thumb 101

Details and patient eligibility

About

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.

Enrollment

7 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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