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NCT Number: NCT06330545

Radiation Therapy for Dupuytren's Contracture Following Non-Surgical Release

The goal of this study is to learn about preventing recurrence of Dupuytren's Contracture. The main question it aims to answer are:

• Does targeted radiation therapy decrease recurrence of Dupuytren's contracture after treatment with Collagenase Clostridium Histolyticum?

Participants will undergo:

* Release of Dupuytren's Contracture after Collagenase Clostridium Histolyticum injection * Daily radiation therapy treatment for 5 days followed by 6-8 week rest period and then another course of 5 days of radiation therapy

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Key information

Conditions

Dupuytren Contracture Connective Tissue Diseases 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

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth Hitchcock

Lebanon, New Hampshire, 03766, United States

Location status: Recruiting

Location contact

Julia Schwarz, MD

CONTACT

[email protected]

6036505133

About this study

This is a prospective phase II trial where patients diagnosed with late/advanced stage Dupuytren's Contracture (DC) who undergo successful Collagenase Clostridium Histolyticum (CCH) injection and release will receive a standardized regimen of adjuvant radiotherapy (RT). The study will be powered to assess the outcome in patients undergoing the combination of successful release followed by RT. Patients will be monitored for acute and late toxicities while we evaluate disease recurrence defined as a > 20 degree worsening of contracture in the presence of a palpable cord as compared to within 14 days from CCH injection, or the need for medical/surgical intervention to correct the new or worsening contracture.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age 45 or greater with DC
  • Extension deficit >10 degrees
  • Unable to simultaneously place the affected finger and palm flat on a table.
  • Women included in the study will be post-menopausal or using contraception, and a pregnancy test will be performed as standard of care.
  • For patients who are having multiple CCH injections, only the first 2 joints on given hand will be included

Exclusion criteria

  • Unsuccessful non-surgical release (> N/1 disease)
  • They develop an open wound during CCH
  • Breast feeding or pregnancy
  • A chronic muscular, neurologic, or neuromuscular disorder affecting the hands.
  • Less than the age of 45
  • They have previously undergone radiation on the hand in which they plan to get CCH injections
  • They are pregnant women, impaired adults or prisoners

Treatment and study plan

radiation therapy

Radiation

Patients with Dupuytren's Contacture will undergo Collagenase Clostridium Histolyticum injection and release followed by two 5-day courses of radiation therapy separated by 6-8 weeks. They will then be followed for 3 years for recurrence.

Primary outcomes

  1. Recurrence of Dupuytren's Contracture

    Time frame: one month, 6 months, 12 months, 24 months, and 36 months post-radiation treatment

    Recurrence defined as > 20 degrees worsening of contracture relative to within 14 days from CCH injection or the need for medical/surgical intervention to correct the new or worsening symptomatic contracture.

    The investigators will measure the contracture using the table top test in which patients their press hand with best of their ability. We will use a goniometer on dorsal surface of hand while performing table top test to measure PIP and MCP joints.

Secondary outcomes

  1. Radiation Toxicity

    Time frame: one month, 6 months, 12 months, 24 months, and 36 months post-radiation treatment

    acute (30 days or less) and late (> 30 days) Grade 2 and Grade 3 toxicities from radiotherapy defined by Radiation Therapy Oncology Group

  2. Patient Reported Outcomes after Radiation Treatment (RT)

    Time frame: Before Radiation Treatment (RT), after completion of RT, 1-month post-RT, 6 months post-RT, 1 year post-RT, 2 years post-RT, and 3 years post-RT

    The investigators will also record hand function change from baseline to after therapy via the Brief Michigan Hand Questionnaire, a patient reported outcome measure. This questionnaire will be used before study enrollment, after completion of RT, one-month post-RT, six months post-RT, one year post-RT, two years post-RT, and three years post-RT. The Michigan Hand Questionnaire is scored from 0-100 with higher scores indicating better functioning and satisfaction.

Study contacts

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

Lance Warhold, MD

CONTACT

603 650-5133

Peter A DePalo, BS, CCRP

CONTACT

[email protected]

603 653-0494

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Official study title

A Prospective Clinical Trial of Radiation Therapy for Dupuytren's Contracture Following Surgical and Non-Surgical Release

Important dates

Study start
2024
Primary completion
2029
Study completion
2032
First posted
Mar 26, 2024
Registry last updated
Jul 28, 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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