Clinical trial · Interventional
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
NCT01265420CI-TRIAL-00017715completedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dupuytren's Contracture | Palmar Fibromatosis | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Injectable clostridial collagenase | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Injectable clostridial collagenase
- description
- Patients with thumb 1st web contracture secondary to Dupuytren's disease will be treated with 0.58mg of collagenase
- interventionNames
- Biological: Injectable clostridial collagenase
Primary outcomes (1)
- measure
- Number Patients Obtaining Clinical Improvement (>50% Reduction in Contracture)
- timeFrame
- 30 days after last injection
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDHurst LC, Badalamente MA, Hentz VR, Hotchkiss RN, Kaplan FT, Meals RA, Smith TM, Rodzvilla J; CORD I Study Group. Injectable collagenase clostridium histolyticum for Dupuytren's contracture. N Engl J Med. 2009 Sep 3;361(10):968-79. doi: 10.1056/NEJMoa0810866. PMID 19726771