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

Indiana Hand to Shoulder Center7 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dupuytren's Contracture

Interventions

Injectable clostridial collagenaseBIOLOGICAL

Injection of 0.58mg clostridial collagenase into Dupuytren's cord, up to three injections

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Indiana Hand to Shoulder Center

Indianaplis, Indiana, United States

Outcomes

Primary Outcomes

Number Patients Obtaining Clinical Improvement (>50% Reduction in Contracture)

Time frame: 30 days after last injection

Data from ClinicalTrials.gov

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