Clinical trial · Interventional
Effectiveness of Splinting After Collagenase Injection
Clinical Effectiveness of Splinting After Collagenase Clostridium Histolyticum Injection for Dupuytren Contracture
- 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)
Dupuytren disease is a fibroproliferative condition of the palmar and digital fascia. A collagen containing cord forms which can lead to fixed flexion contracture of one or more fingers. While there is no cure, many treatment options are available to manage symptoms. One of these options is injectable collagenase clostridium histolyticum (CCH). CCH is a combination of two highly selective microbial collagenases that can disrupt collagen types I and III usually found in cords. Current standard of care after receiving a CCH injection is daily hand exercises and use of a static night brace for four months. However, there is limited evidence that use of a night splint after CCH injection has any benefit post-treatment. The goal of our randomized, controlled trial, is to determine the clinical effectiveness of splinting after CCH injection. Study subjects will be adults 18 years of age or older with Dupuytren disease and contracture of one or more digits. Treatment includes collagenase clostridium histolyticum injection for Dupuytren flexion contraction, with randomization to static night splint or no splint.
Conditions
Conditions (2)
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 Contracture | Palmar Fibromatosis | ALIAS | 0.90 |
| Dupuytren's Disease | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex] | Drug | — | UNRESOLVED |
| Xiaflex + Hand-Based Custom Orthosis | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- No Splint Group
- description
- This group will receive Xiaflex injection only
- interventionNames
- Drug: Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex]
- type
- ACTIVE_COMPARATOR
- label
- Splint Group
- description
- This group will receive Xiaflex injection and hand-based custom orthosis to maintain finger extension
- interventionNames
- Combination Product: Xiaflex + Hand-Based Custom Orthosis
Primary outcomes (3)
- measure
- Improvement in active extension deficit of MCP joint, in degrees, if applicable
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years or older * Contracture of 1 or more digits caused by palpable cord * PIP joint flexion contracture of 20 degrees or more or; * MCP joint flexion contracture of 20 degrees or more Exclusion Criteria: * Age less than 18 years * Prior CCH injection for contracture less than 1 year before start of study * Prior surgical intervention for contracture less than 1 year before start of study
References
Publications (3)
- BACKGROUNDRayan GM. Dupuytren disease: Anatomy, pathology, presentation, and treatment. J Bone Joint Surg Am. 2007 Jan;89(1):189-98. doi: 10.2106/00004623-200701000-00026. No abstract available. PMID 17256226
- 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
- BACKGROUNDBowers NL, Merrell GA, Foster T, Kaplan FTD. Does Use of a Night Extension Orthosis Improve Outcomes in Patients With Dupuytren Contracture Treated With Injectable Collagenase? J Hand Surg Glob Online. 2021 Jun 26;3(5):272-277. doi: 10.1016/j.jhsg.2021.05.001. eCollection 2021 Sep. PMID 35415567