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Efficacy and Safety of Xiaflex Injection for Treatment of Dupuytren's Contracture of the Thumb | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

The Efficacy and Safety of Xiaflex Injections for the Treatment of Thumb Cords in Dupuytren's Contractures

NCT01265420•Indiana Hand to Shoulder Center

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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

Key Dates

Start Date

December 1, 2010

Primary Completion Date

February 1, 2014

Completion Date

February 1, 2014

Last Updated

April 30, 2015

Enrollment

ACTUAL participants

Conditions

Dupuytren's Contracture

Interventions

Injectable clostridial collagenase

BIOLOGICAL

Real-World Data Study to Understand Participant Treatment Outcomes for Dupuytren's Contracture

NCT05877066

Dupuytren's Contracture

View study

COMPLETED

Ultrasound B Mode Imaging and Elastography

NCT04607187

Dupuytren's Contractures

View study

COMPLETEDPHASE3

Collagenase Option for Reduction of Dupuytren's Contracture in Japan

NCT01588353

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 30, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Real-World Data Study to Understand Participant Treatment Outcomes for Dupuytren's Contracture

Ultrasound B Mode Imaging and Elastography

Collagenase Option for Reduction of Dupuytren's Contracture in Japan

Phase II Randomized Study of Collagenase in Patients With Residual Type Dupuytren's Disease

Phase III Randomized Study of Collagenase in Patients With Residual Stage Dupuytren's Disease

Treatment Of Dupuytren's Contracture With Collagenase Clostridium Histolyticum Injection (Xiapex)