NCT07661342

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P25-P50 for phase_3

Timeline
29mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 22, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2028

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2028

Last Updated

June 22, 2026

Status Verified

June 1, 2026

Enrollment Period

2 years

First QC Date

June 16, 2026

Last Update Submit

June 16, 2026

Conditions

Dupuytren's Contracture

Outcome Measures

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).

    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 (4)

  • 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

    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)

    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

    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

Study Arms (2)

Radiation Therapy

EXPERIMENTAL

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

Radiation: Radiation Therapy

Standard of Care

NO INTERVENTION

Patients are receiving standard of care.

Interventions

Radiation TherapyRADIATION

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.

Radiation Therapy

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Greenwich Hospital

Greenwich, Connecticut, 06830, United States

Location

MeSH Terms

Conditions

Dupuytren Contracture

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

FibromaNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsContractureMuscular DiseasesMusculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Bruce McGibbon, MD

    Yale University

    PRINCIPAL INVESTIGATOR

  • Frank D Buono, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruce McGibbon, MD

CONTACT

203-8633-701bruce.mcgibbon@yale.edu

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2026

First Posted

June 22, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

July 30, 2028

Study Completion (Estimated)

December 30, 2028

Last Updated

June 22, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)