DEPART Study at Yale (Dupuytren's)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dupuytren's Contracture
• Intervention / Treatment: Radiation: Radiation Therapy

• Study Type: Interventional
• Enrollment (Estimated): 158
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Bruce McGibbon, MD; Phone Number: 203-8633-701; Email: bruce.mcgibbon@yale.edu

Study Locations

• United States
  • Connecticut
    • Greenwich, Connecticut, United States, 06830
      • Greenwich Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radiation Therapy; early stage DD (no flexion contraction in affected hand) - randomized to Radiotherapy	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.
No Intervention: Standard of Care; Patients are receiving standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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

Outcome Measure	Measure Description	Time Frame
Number of participants with any adverse events of interest	Number of participants with any adverse events of interest	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	Mean Visual Analogue Scale (VAS 0-10) for pain, higher scores indicate more pain.	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)	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.	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	QuickDASH (total score) for physical fundctionand symptoms, is an 11 item scale with total score range 0-100. Higher scores mean more severe disability.	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

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Bruce McGibbon, MD, Yale University; Principal Investigator: Frank D Buono, PhD, Yale University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): December 30, 2028

Study Registration Dates

• First Submitted: June 16, 2026
• First Submitted That Met QC Criteria: June 16, 2026
• First Posted (Actual): June 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Neoplasms; Connective Tissue Diseases; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Neoplasms, Connective Tissue; Neoplasms, Fibrous Tissue; Fibroma; Contracture; Skin and Connective Tissue Diseases; Dupuytren Contracture; Therapeutics; Radiotherapy
• Other Study ID Numbers: 2000041630; ACTRN12618000951257p (Other Identifier: Australian government)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No