DEPART Study at Yale
Part of paid clinical trials in Greenwich, Connecticut.
- Sponsor
- Yale University
- Study ID
- NCT07661342
- Phase
- PHASE3
- Status
- Not Yet Recruiting
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Conditions
- Dupuytren's Contracture
Eligibility Criteria
- Sex
- ALL
- Age
- 30 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Radiation Therapy — RADIATIONRadiation therapy (RT) should commence within 12 weeks of randomization in the prevention group and within 12 weeks of local treatment (NA) for the adjuvant group. RT will consist of 30Gy in 10 equal fractions. The RT schedule will be 5 initial fractions, then a 4-12 week break and then the final 5 fractions. Each group of 5 treatments must be delivered within a 7 day period.
Study Details
This is a randomized study to determine whether radiation therapy reduces the risk of progression / recurrence of Dupuytren's disease / contracture.
Key Dates
- Start date
- Aug 1, 2026
- Status verified
- Jun 2026
- Primary completion
- Jul 30, 2028
- Completion
- Dec 30, 2028
Study Design
- Enrollment
- 158 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Radiation Therapyearly stage DD (no flexion contraction in affected hand) - randomized to Radiotherapy
- No Intervention: Standard of CarePatients are receiving standard of care.
Primary Outcome Measure
Number of Participants with Passive Extension Deficit (PED) [ Time Frame: Day 0 (corresponding to the day of local treatment for intervention groups) and then at 6, 12, 24, 36, 48, 60, 84 and 108 months ]
Central Contacts
- Bruce McGibbon, MD203-8633-701
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Greenwich Hospital | Greenwich | Connecticut | 06830 | - |
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