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NCT Number: NCT07661342

DEPART Study at Yale

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

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Key information

Conditions

Dupuytren's Contracture Connective Tissue Diseases Contracture Dupuytren Contracture Fibroma Muscular Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibrous Tissue Skin and Connective Tissue Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Greenwich Hospital

Greenwich, Connecticut, 06830, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

    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).

Secondary outcomes

  1. 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

    Number of participants with any adverse events of interest

  2. 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

    Mean Visual Analogue Scale (VAS 0-10) for pain, higher scores indicate more pain.

  3. 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

    URAM (total score) for Dupuytren's disease specific function, is a 9-item scale with total scores ranging from 0 to 45. Higher scores mean greater disability.

  4. 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

    QuickDASH (total score) for physical fundctionand symptoms, is an 11 item scale with total score range 0-100. Higher scores mean more severe disability.

Study contacts

Contact information is provided by the study sponsor or research team.

Bruce McGibbon, MD

CONTACT

[email protected]

203-8633-701

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

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

Acronym: Dupuytren's

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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