DEPART Study at Yale

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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07661342

Acronym

Dupuytren's

Enrollment

158

Registered

2026-06-22

Start date

2026-08-01

Completion date

2028-12-30

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dupuytren's Contracture

Brief summary

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

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants with Passive Extension Deficit (PED)	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

Measure	Time frame	Description
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	Number of participants with any adverse events of interest
Mean Pain Score	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.
Total Score Unité Rhumatologique des Affections de la Main (URAM)	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.
Total Score QuickDASH	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.

Countries

United States

Contacts

CONTACTBruce McGibbon, MD

bruce.mcgibbon@yale.edu203-8633-701

PRINCIPAL_INVESTIGATORBruce McGibbon, MD

Yale University

PRINCIPAL_INVESTIGATORFrank D Buono, PhD