DEPART Study at Yale

Phase 3Not Yet RecruitingNCT07661342

Yale University158 enrolled

Overview

This is a randomized study to determine whether radiation therapy reduces the risk of progression / recurrence of Dupuytren's disease / contracture.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

158

Conditions

Dupuytren's Contracture

Interventions

Radiation TherapyRADIATION

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.

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

Inclusion Criteria: * English-speaking * Patient consent * No previous radiotherapy to the affected hand * No history of radiation sensitivity diseases (e.g. Scleroderma, Ataxia Telangiectasia, Li Fraumeni) * Age\>30 * Life expectancy \>5 years * Available and willing to participate in at least 5 years of follow-up * Female patients capable of child-bearing that are not pregnant Exclusion Criteria: * Pregnancy or lactation * Known genetic disease that would make them extremely sensitive to radiation therapy, e.g. Scleroderma, Ataxia Telangiectasia, Li Fraumeni

Locations (1)

Greenwich Hospital

Greenwich, Connecticut, United States

Outcomes

Primary Outcomes

Number of Participants with Passive Extension Deficit (PED)

Deterioration greater than 20 degrees Passive Extension Deficit (PED) in any joint(s) of any of the affected digit(s) from post-intervention baseline in the presence of a palpable cord OR instigation of salvage surgical fasciectomy (SF) or NA to any of the affected digit(s).