Dupuytren ContractureNCT06330545
Radiation Therapy for Dupuytren's Contracture Following Non-Surgical Release
A study testing Radiation therapy in people with Dupuytren Contracture, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dupuytren Contracture
- What is being tested?
- Radiation therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2024to Apr 2032
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lance Warhold, MD contact
United States1 site, 1 recruiting
- Recruiting
Dartmouth Hitchcock
Lebanon, New Hampshire, 03766
Julia Schwarz, MD, 6036505133, julia.s.schwarz@hitchcock.org
About this study
Official title: A Prospective Clinical Trial of Radiation Therapy for Dupuytren's Contracture Following Surgical and 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
Read the detailed description
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.
- Conditions
- Dupuytren Contracture
- Being tested
- Radiation therapy
- Keywords
- Dupuytren's contracture, radiation therapy
- Medical subject headings
- Dupuytren Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation therapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Dupuytren's Contacture | Experimental | 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. Receives: Radiation: Radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of Dupuytren's Contracture
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.
Measured: one month, 6 months, 12 months, 24 months, and 36 months post-radiation treatment
Secondary outcomes (2)
Radiation Toxicity
acute (30 days or less) and late (> 30 days) Grade 2 and Grade 3 toxicities from radiotherapy defined by Radiation Therapy Oncology Group
Measured: one month, 6 months, 12 months, 24 months, and 36 months post-radiation treatment
Patient Reported Outcomes after Radiation Treatment (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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start16 Sep 2024
- Primary completionApr 2029 (estimated)
- Study completionApr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dupuytren ContractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective phase II trial where patients diagnosed with late/advanced stage Dupuytren's Contracture (DC) who undergo successful CCH injection and release will receive a standardized regimen of 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, or the need for medical/surgical intervention to correct the new or worsening contracture.
- Masking
- None (open label)
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lance G. Warhold, Dartmouth-Hitchcock Medical Center
- Investigators
- Lance Warhold, MD, Principal investigator, Dartmouth Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330545
- Sponsor's protocol ID
- STUDY02002161
- Status last verified
- Jul 2026
- First submitted
- 19 Mar 2024
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No