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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month and 4 months
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
No Placebo-Only Group

Summary

This trial tests an injectable enzyme treatment for adults with Dupuytren disease, which causes stiff, bent fingers. The enzyme breaks down tough tissue in the hand, helping fingers to straighten. The study will compare outcomes with and without using a night splint after the injection.

Eligible Conditions
  • Dupuytren's Contracture

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
Compliance of Splint wearing (Splint group only)
Functional Outcomes
Patient Satisfaction

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

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Who is running the clinical trial?

EndoPharmceuticalsUNKNOWN
Foundation for Orthopaedic Research and EducationLead Sponsor
14 Previous Clinical Trials
921 Total Patients Enrolled
Jason Nydick, DOPrincipal InvestigatorFlorida Orthopaedic Institute
~18 spots leftby Nov 2025
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