Phase 4
Completed N=7
Efficacy and Safety of Xiaflex Injection for Treatment of Dupuytren's Contracture of the Thumb
Dupuytren's Contracture
Source: ClinicalTrials.gov NCT01265420 ↗
Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcomePrimary: Number Patients Obtaining Clinical Improvement (>50% Reduction in Contracture) — 5; 1 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number Patients Obtaining Clinical Improvement (>50% Reduction in Contracture) |
5; 1 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01265420). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.