AzTrials
AzTrials

Dupuytren ContracturePhase 3NCT04874870

Effectiveness of Splinting After Collagenase Injection

A Phase 3 study testing Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex] and Xiaflex + Hand-Based Custom Orthosis in people with Dupuytren Contracture and Dupuytren's Disease, run by Foundation for Orthopaedic Research and Education at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Dupuytren Contracture, Dupuytren's Disease
What is being tested?
Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex] and Xiaflex + Hand-Based Custom Orthosis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
12 Jul 2021to 1 Dec 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Florida Orthopaedic Institute

    Tampa, Florida, 33637

Other trials in United States

About this study

Official title: Clinical Effectiveness of Splinting After Collagenase Clostridium Histolyticum Injection for Dupuytren Contracture

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.

Read the detailed description

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.

Being tested
Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex], Xiaflex + Hand-Based Custom Orthosis
Medical subject headings
Dupuytren Contracture

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex]Drug

    Also called Xiaflex

    1 injection of 0.58mg will be injected into applicable cord.

  • Xiaflex + Hand-Based Custom OrthosisCombination product

    1 injection of 0.58mg will be injected into applicable cord followed by use of hand-based custom orthosis to maintain finger extension

Study groups in NCT04874870
Study groupRoleWhat they receive
No Splint GroupActive comparatorThis group will receive Xiaflex injection only
Receives: Drug: Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex]
Splint GroupActive comparatorThis group will receive Xiaflex injection and hand-based custom orthosis to maintain finger extension
Receives: Combination Product: Xiaflex + Hand-Based Custom Orthosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline, 1 month, and 4 months

  2. 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

    Measured: Baseline, 1 month, and 4 months

  3. Improvement in total active extension of each digit, in degrees

    Sum of MCP and PIP joint extension, in degrees, of treated finger

    Measured: Baseline, 1 month, and 4 months

Secondary outcomes (3)

  1. 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?

    Measured: 1 month and 4 months

  2. 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).

    Measured: Baseline, 1 month, and 4 months

  3. 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?

    Measured: 1 month and 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2021
  2. Study start12 Jul 2021
  3. Primary completion1 Dec 2023
  4. Study completion1 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, Controlled
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04874870
Sponsor's protocol ID
FORE- CHI 2021
Status last verified
Feb 2025
First submitted
23 Apr 2021
Last updated
26 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Pending results- the plan would be to submit a poster for presentation and a manuscript for publication.

Publications

  • Rayan 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.

    PubMed 17256226

  • Hurst 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.

    PubMed 19726771

  • Bowers 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.

    PubMed 35415567

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex] and Xiaflex + Hand-Based Custom Orthosis in people with Dupuytren Contracture and Dupuytren's Disease, run by Foundation for Orthopaedic Research and Education at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement in active extension deficit of MCP joint, in degrees, if applicable (time frame: Baseline, 1 month, and 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04874870, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025.

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