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Enzyme

Xiaflex + Orthosis for Dupuytren's Contracture

Phase 3
Waitlist Available
Led By Jason Nydick, DO
Research Sponsored by Foundation for Orthopaedic Research and Education
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
PIP joint flexion contracture of 20 degrees or more or;
MCP joint flexion contracture of 20 degrees or more
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month and 4 months
Awards & highlights

Study Summary

This trial is testing whether using a night splint after receiving an injection of collagenase clostridium histolyticum (CCH) has any benefit for people with Dupuytren disease.

Eligible Conditions
  • Dupuytren's Contracture

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have a condition where you can't fully bend your finger at the middle joint (PIP joint) by at least 20 degrees.
Select...
You are unable to bend your finger joint more than 20 degrees.
Select...
You have a finger that is bent and difficult to move due to a tight cord-like structure that can be felt.
Select...
You have tightness or stiffness in one or more fingers caused by a thickened cord.
Select...
You have a finger joint that is bent more than 20 degrees and cannot straighten fully.
Select...
Your finger joint cannot bend more than 20 degrees.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month and 4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month and 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Improvement in active extension deficit of MCP joint, in degrees, if applicable
Improvement in active extension deficit of PIP joint, in degrees, if applicable
Improvement in total active extension of each digit, in degrees
Secondary outcome measures
Compliance of Splint wearing (Splint group only)
Functional Outcomes
Patient Satisfaction

Trial Design

2Treatment groups
Active Control
Group I: No Splint GroupActive Control1 Intervention
This group will receive Xiaflex injection only
Group II: Splint GroupActive Control1 Intervention
This group will receive Xiaflex injection and hand-based custom orthosis to maintain finger extension

Find a Location

Who is running the clinical trial?

Foundation for Orthopaedic Research and EducationLead Sponsor
11 Previous Clinical Trials
916 Total Patients Enrolled
EndoPharmceuticalsUNKNOWN
Jason Nydick, DOPrincipal InvestigatorFlorida Orthopaedic Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly individuals being considered for this clinical trial?

"According to the age requirements specified in the study's inclusion criteria, participants must be between 18 and 90 years old."

Answered by AI

Would I be a qualified candidate for this clinical trial?

"This ongoing medical trial needs 80 individuals, who must be aged 18 to 90 and have a current diagnosis of dupuytren's disease. In addition, all study participants must meet at least one of the following conditions: PIP joint flexion contracture of 20 degrees or more or;, Age 18 years or older, Contracture of 1 or more digits caused by palpable cord, MCP joint flexion contracture of 20 degrees or more."

Answered by AI

Does Splint Group have the FDA's blessing?

"There is some evidence of efficacy and multiple rounds of data supporting safety, which gives Splint Group a score of 3 on our team's 1 to 3 scale."

Answered by AI

What is the total number of patients that will be participating in this clinical trial?

"There are no open enrolment periods for this study at the moment. The trial was first announced on July 12th, 2021 and has since been updated on August 16th, 2021. However, if you are interested in other studies, there are 21 clinical trials related to Dupuytren's disease and 6 studies related to Splint Group that are currently looking for participants."

Answered by AI

For what sort of patients is Splint Group most often prescribed?

"The Splint Group intervention is effective for treating conditions such as a palpable cord, skin ulcer, and penile deformity at an angle of 30 degrees or more."

Answered by AI

Could you please list the other scientific research projects that Splint Group has undertaken?

"There are six ongoing clinical trials studying Splint Group, one of which is in Phase 3. The vast majority of research is being conducted in Orem, Utah; however, there are 11 total research centres for Splint Group."

Answered by AI

Are currently enrolling patients in this clinical trial?

"Currently, this clinical trial is not recruiting patients. However, at the time this information was last updated on clinicaltrials.gov, there were 27 other trials that were actively recruiting."

Answered by AI

Who else is applying?

What state do they live in?
Arkansas
Georgia
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
~22 spots leftby Mar 2025