Effectiveness of Splinting After Collagenase Injection

Completed · Phase 3

Conditions studied: Dupuytren Contracture, Dupuytren's Disease

In brief

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.

Key facts

Study ID
NCT04874870
Run by
Foundation for Orthopaedic Research and Education
People needed
80
Starts
2021-07-12
Expected to finish
2023-12-01
Last updated by the study team
2025-02-26

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

You may not qualify if…

Where it is running

Full record on ClinicalTrials.gov

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