A Phase 3 interventional study of Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex] and Xiaflex + Hand-Based Custom Orthosis in Dupuytren Contracture and Dupuytren's Disease, sponsored by Foundation for Orthopaedic Research and Education. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-26.
Sponsored by Foundation for Orthopaedic Research and Education · Phase 3, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 17 studies testing Microbial Collagenase in Dupuytren Contracture — none open to participants now, 1 under way, none of them phase 3. Microbial Collagenase · Dupuytren Contracture.
Among the 17 studies testing Microbial Collagenase in Dupuytren Contracture, this one is the 7th largest by enrollment, is the only one that started in 2021, is one of 7 in phase 3, and was the 17th registered.
78 studies on the registry are indexed under Dupuytren Contracture; 18 are open to participants now.
Browse Dupuytren Contracture studies →None of the 17 studies testing Microbial Collagenase in Dupuytren Contracture is open now. The open studies under Dupuytren Contracture, anywhere →
Microbial Collagenase: first FDA approval 1965 (SANTYL), first EMA approval 2011. What it is approved for, and how studies give it, is on its page →
Of the 12 Dupuytren Contracture studies recruiting now, 10 (83%) set no upper age limit and 1 (8%) stops at 75 or younger; 1 takes children under 18; 2 take healthy volunteers.
This study: 18 Years to 90 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
17 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2021.
This study's enrollment of 80 is above the median of 72 across 57 interventional studies indexed under Dupuytren Contracture.
Median enrollment 76 across the 17 interventional studies. Of the 15 that completed or were terminated, 12 (80%) have results posted.
This tab as a report to print or save as PDF → With an account.
8 of 17 have an industry lead sponsor. The 10 most frequent:
Foundation for Orthopaedic Research and Education is the lead sponsor of 17 studies on the registry; 4 are open to participants now.
Foundation for Orthopaedic Research and Education has 1 study filed under Dupuytren Contracture — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 17 studies testing Microbial Collagenase in Dupuytren Contracture, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
Patients with Dupuytren disease that meet inclusion criteria will be consented to participate. All patients will be randomized to splint or no splint group prior to treatment. Baseline data will be collected prior to treatment and will include demographics, measurement of joint flexion contracture(s) with a standard finger goniometer, and QuickDASH scores. All patients that participate will receive 1 injection of 0.58 mg of CCH into cord. After 24-48 hours, if needed, patient will return to clinic for extension manipulation of treated finger(s) to help facilitate rupture of cord. Following injection and/or manipulation, all patients will be instructed to perform a series of finger exercises daily that they will receive from a hand therapist. In addition, patients assigned to the splint group will be fitted for a static night splint that they will be instructed to wear nightly for 4 months. Splint compliance will be recorded by a survey at each follow up visit. Patients will return to clinic for routine follow up care at 1 month and 4 months during which their degree of contracture(s) and outcomes will be measured and recorded. The primary outcome measures of this study are improvement in active extension deficit of each joint and total active extension of each digit, in degrees. The secondary outcome measures are QuickDASH scores and patient satisfaction.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
This group will receive Xiaflex injection only
Drug: Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex]
This group will receive Xiaflex injection and hand-based custom orthosis to maintain finger extension
Combination Product: Xiaflex + Hand-Based Custom Orthosis
1 injection of 0.58mg will be injected into applicable cord.
Also known as: Xiaflex
1 injection of 0.58mg will be injected into applicable cord followed by use of hand-based custom orthosis to maintain finger extension
Improvement in active extension deficit of MCP joint, in degrees, if applicable
Clinical measurement of MCP joint extension with goniometer, in degrees, of treated finger
Time frame: Baseline, 1 month, and 4 months
Improvement in active extension deficit of PIP joint, in degrees, if applicable
Clinical measurement of PIP joint extension with goniometer, in degrees, of treated finger
Time frame: Baseline, 1 month, and 4 months
Improvement in total active extension of each digit, in degrees
Sum of MCP and PIP joint extension, in degrees, of treated finger
Time frame: Baseline, 1 month, and 4 months
Compliance of Splint wearing (Splint group only)
By compliance survey composed of 4 items Items 1 and 2 scored from 1-5; 1 - not at all, 2 - slightly, 3- moderately, 4- very, 5- extremely How comfortable was your splint? Was the splint easy to use? Items 3 and 4 scored from 1-5; 1 - not at all, 2 - occasionally, 3- half of the time, 4 - most of the time, 5 - all of the time Did you wear your splint every night? Did you have any issues with your splint?
Time frame: 1 month and 4 months
Functional Outcomes
Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire score will be used to measure clinical outcomes. The QuickDASH is scored in two components: the disability/symptom section (11 items, scored 1-5) and the optional high performance sport/music or work modules (four items, scored 1-5). From the item scores, scale scores are calculated, ranging from 0 (no disability) to 100 (most severe disability).
Time frame: Baseline, 1 month, and 4 months
Patient Satisfaction
By satisfaction scale composed of 3 items (each of them scored from 1-5; 1 - not at all, 2 - slightly, 3- moderately, 4- very, 5- extremely) How satisfied are you with the progress of your hand? How satisfied are you with your treatment? Has your quality of life improved?
Time frame: 1 month and 4 months
Plan to share: No — Pending results- the plan would be to submit a poster for presentation and a manuscript for publication.
Ran from Jul 2021 to primary completion in Dec 2023, 28 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Microbial Collagenase
Foundation for Orthopaedic Research and Education