ClinicalTrials.gg
Not yet recruitingNCT07661342Dupuytren'sUpdated Oct 13, 2026

DEPART Study at Yale

A Phase 3 interventional study of Radiation Therapy in Dupuytren's Contracture, sponsored by Yale University. Not yet recruiting at 1 site in United States. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Yale University · Phase 3, Interventional, and Treatment

Updated Oct 13, 2026Start date movedGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
158
Allocation
Randomized
Ages
30 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Dupuytren's Contracture

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03

In context

Dupuytren Contracture

78 studies on the registry are indexed under Dupuytren Contracture; 18 are open to participants now.

This study's planned enrollment of 158 is above the median of 72 across 57 interventional studies indexed under Dupuytren Contracture.

Browse Dupuytren Contracture studies →

Lead sponsor

Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.

Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • >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

Exclusion Criteria:

  • Pregnancy or lactation
  • Known genetic disease that would make them extremely sensitive to radiation therapy, e.g. Scleroderma, Ataxia Telangiectasia, Li Fraumeni
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
158 participants (estimated)

Study arms

  • Experimental
    Radiation Therapy

    early stage DD (no flexion contraction in affected hand) - randomized to Radiotherapy

    Radiation: Radiation Therapy

  • No intervention
    Standard of Care

    Patients are receiving standard of care.

Interventions

  • RadiationRadiation 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.

06

What researchers measure

Primary outcomes

  1. 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).

    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 outcomes

  1. Number of participants with any adverse events of interest

    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

  2. Mean Pain Score

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

    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

  3. 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.

    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

  4. 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.

    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

07

Study locations

1 site
  • Greenwich Hospital
    Greenwich, Connecticut 06830, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Start date
Aug 1, 2026→Nov 1, 2026
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    Start date Aug 1, 2026→Nov 1, 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07661342
Lead sponsor
Yale University
Responsible party
Sponsor
First posted
Jun 22, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Jul 30, 2028 (estimated)
Completion
Dec 30, 2028 (estimated)
Last update
Oct 13, 2026

Study contacts

Bruce McGibbon, MD
Contact
bruce.mcgibbon@yale.edu
203-8633-701
Bruce McGibbon, MD
principal investigator · Yale University
Frank D Buono, PhD
principal investigator · Yale University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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