Phase 4 N=7 Treatment

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

Dupuytren's Contracture

Bottom Line

View on ClinicalTrials.gov: NCT01265420 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2015

Primary outcome: Primary: Number Patients Obtaining Clinical Improvement (>50% Reduction in Contracture) — 5; 1 participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Injectable clostridial collagenase (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Indiana Hand to Shoulder Center
Primary completion: Feb 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Number Patients Obtaining Clinical Improvement (>50% Reduction in Contracture)	5; 1	—

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 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

View full record on ClinicalTrials.gov →

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.