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

NCT01265420 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2015-04-30

Study results available
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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.

Conditions

  • Dupuytren's Contracture

Interventions

BIOLOGICAL

Injectable clostridial collagenase

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

Sponsors & Collaborators

  • Indiana Hand to Shoulder Center

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • United States

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01265420 on ClinicalTrials.gov