Clinical trial
Clinical Effectiveness of Splinting After Collagenase Clostridium Histolyticum Injection for Dupuytren Contracture
Name
FORE- CHI 2021
Description
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.
Trial arms
Trial start
2021-07-12
Estimated PCD
2023-12-01
Trial end
2023-12-01
Status
Completed
Phase
Early phase I
Treatment
Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex]
1 injection of 0.58mg will be injected into applicable cord.
Arms:
No Splint Group
Other names:
Xiaflex
Xiaflex + Hand-Based Custom Orthosis
1 injection of 0.58mg will be injected into applicable cord followed by use of hand-based custom orthosis to maintain finger extension
Arms:
Splint Group
Size
80
Primary endpoint
Improvement in active extension deficit of MCP joint, in degrees, if applicable
Baseline, 1 month, and 4 months
Improvement in active extension deficit of PIP joint, in degrees, if applicable
Baseline, 1 month, and 4 months
Improvement in total active extension of each digit, in degrees
Baseline, 1 month, and 4 months
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, Controlled', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 80, 'type': 'ACTUAL'}}
Updated at
2024-05-01
1 organization
2 products
1 indication
Indication
Dupuytren's ContractureProduct
Xiaflex