Actively Recruiting
Radiation Therapy for Dupuytren's Contracture After Non-Surgical and Surgical Release A Prospective Clinical Trial Evaluating Recurrence Prevention
Led by Dartmouth-Hitchcock Medical Center · Updated on 2024-11-22
95
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether targeted radiation therapy can help prevent the return of Dupuytren's Contracture after treatment with Collagenase Clostridium Histolyticum (CCH). This phase II trial involves patients with late or advanced stage Dupuytren's Contracture who have successfully undergone CCH injection and release. The study aims to assess disease recurrence, defined as a worsening contracture of more than 20 degrees with a palpable cord or the need for further medical or surgical treatment, while monitoring for any radiation-related side effects. Participants will first receive a non-surgical release of Dupuytren's Contracture through CCH injection. Following this, they will undergo two courses of radiation therapy, each lasting five days, separated by a 6 to 8 week rest period. After completing these treatments, participants will be followed closely for up to three years to monitor for any recurrence of the contracture. During the study, participants will have regular assessments to track the contracture's status at one month, six months, one year, two years, and three years after radiation therapy. Researchers will also evaluate any radiation side effects and gather patient-reported outcomes throughout this period. The total participation time includes these follow-up visits to understand both the effectiveness and safety of combining CCH release with radiation therapy.
CONDITIONS
Brief Title
Radiation Therapy for Dupuytren's Contracture Following Non-Surgical Release
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 45 or greater with Dupuytren's Contracture
- Finger extension deficit greater than 10 degrees
- Unable to place the affected finger and palm flat on a table simultaneously
- Women must be post-menopausal or using contraception; pregnancy test performed as standard care
- Only first two joints on a given hand included if multiple injections are given
You will not qualify if you...
- Unsuccessful non-surgical release
- Presence of an open wound during Collagenase Clostridium Histolyticum injection
- Breastfeeding or pregnancy
- Chronic muscular, neurologic, or neuromuscular disorder affecting the hands
- Under age 45
- Previous radiation on the hand planned for injection
- Pregnant women, impaired adults, or prisoners
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Approximately 12 weeks
Participants undergo Collagenase Clostridium Histolyticum injection and release followed by two 5-day courses of radiation therapy separated by 6 to 8 weeks.
Multiple visits for injections and radiation therapy sessions
Duration - 3 years
Participants are followed for 3 years to monitor for recurrence of Dupuytren's Contracture and radiation-related toxicities.
Visits at 1 month, 6 months, 12 months, 24 months, and 36 months post-radiation treatment
Trial Site Locations
Total: 1 location
1
Dartmouth Hitchcock
Lebanon, New Hampshire, United States, 03766
Actively Recruiting
Research Team
J
Julia S Schwarz, MD
L
Lance Warhold, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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