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NCT04874870 · ClinicalTrials.gov registry record · Phase 3
Effectiveness of Splinting After Collagenase Injection
A Phase 3 study of Dupuytren Contracture and Dupuytren's Disease, sponsored by Foundation for Orthopaedic Research and Education.
- Completed
- Registry status
- Phase 3
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT04874870: Completed Phase 3 study of Dupuytren Contracture and Dupuytren's Disease, sponsored by Foundation for Orthopaedic Research and Education.
NCT04874870 is a Phase 3 study of Dupuytren Contracture and Dupuytren's Disease that has completed, run by Foundation for Orthopaedic Research and Education. The registered enrollment target is 80 participants, roughly in line with the 79-participant average among 4 other Dupuytren Contracture trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04874870, a Phase 3 study of Dupuytren Contracture and Dupuytren's Disease, has completed, sponsored by Foundation for Orthopaedic Research and Education.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Clinical measurement of MCP joint extension with goniometer, in degrees, of treated finger
Conditions Studied
Interventions
- DRUG Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex]
- COMBINATION_PRODUCT Xiaflex + Hand-Based Custom Orthosis
Study Locations (1)
Florida
- Florida Orthopaedic Institute - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2021-07-12 |
| Est. Completion | 2023-12-01 |
| Phase | Phase 3 |
What the finished NCT04874870 record still lists
NCT04874870 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, roughly in line with the 79-participant average among 4 other Dupuytren Contracture trials with a reported enrollment target.
The record links to 2 conditions, with Dupuytren Contracture appearing as the primary indexed condition, and to 2 interventions - of which Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex] is the first listed.
NCT04874870 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT04874870 about?
NCT04874870 is a clinical study titled "Effectiveness of Splinting After Collagenase Injection". 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 injectab...
What is the current status of trial NCT04874870?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 80 participants. The study started on 2021-07-12. Estimated completion is 2023-12-01.
What conditions does trial NCT04874870 study?
This clinical trial studies the following conditions: Dupuytren Contracture, Dupuytren's Disease.
What interventions are being tested in trial NCT04874870?
The interventions under investigation include: Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex] (DRUG), Xiaflex + Hand-Based Custom Orthosis (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04874870?
This trial is sponsored by Foundation for Orthopaedic Research and Education, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04874870 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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