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 — RADIATION
    Radiation 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 Therapy
    early stage DD (no flexion contraction in affected hand) - randomized to Radiotherapy
  • No Intervention: Standard of Care
    Patients 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

Locations (1)

FacilityCityStateZIPSite coordinators
Greenwich HospitalGreenwichConnecticut06830-

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