Not yet recruiting NCT07661342

DEPART Study at Yale

Phase III Interventional Dupuytren's Contracture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Radiation Therapy.
Who it may be relevant to: Registry conditions: Dupuytren's Contracture. Basic parameters: from 30 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

Dupuytren's Disease Evaluation of Preventative or Adjuvant Radiation Therapy: DEPART

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

Radiation Radiation Therapy
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.

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]

Secondary outcome measures (4)

Number of participants with any adverse events of interest [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]
Mean Pain Score [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]
Total Score Unité Rhumatologique des Affections de la Main (URAM) [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]
Total Score QuickDASH [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]

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

Pregnancy or lactation
Known genetic disease that would make them extremely sensitive to radiation therapy, e.g. Scleroderma, Ataxia Telangiectasia, Li Fraumeni

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

United States · 1 center

NCT: NCT07661342 · 2000041630 · ACTRN12618000951257p