Clinical trial · Interventional
Safety and Efficacy of Delayed Manipulation After Xiaflex Treatment in Subjects With Dupuytren's Contracture
A Post Market, Open-Label Study of the Safety and Efficacy of Delayed Manipulation After Xiaflex Treatment in Subjects With Dupuytren's Contracture
NCT01226121CI-TRIAL-00014847terminatedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): difficulty enrolling additional patients
Summary
Brief summary (as posted)
The purpose of this study is to determine if of manipulation of digits following collagenase injection for treatment of Dupuytren's contracture is effected by the amount of time between injection and manipulation.
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 Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clostridial collagenase injectable | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Day 1 manipulation
- description
- Finger manipulation one day following Clostridial collagenase injectable
- interventionNames
- Biological: Clostridial collagenase injectable
- type
- ACTIVE_COMPARATOR
- label
- Day 2 manipulation
- description
- Finger manipulation two days following Clostridial collagenase injectable
- interventionNames
- Biological: Clostridial collagenase injectable
- type
- ACTIVE_COMPARATOR
- label
- Day 4 manipulation
- description
- Finger manipulation four days following Clostridial collagenase injectable
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 metacarpophalangeal joint contracture and a palpable cord of \> 20 degrees of a digit (excluding the thumb) due to Dupuytren's contracture Exclusion Criteria: * Any subject who has had prior surgical, percutaneous needle aponeurotomy or Xiaflex treatment for Dupuytren's contracture. * 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). * 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