Using radiation therapy to prevent Dupuytren's contracture recurrence after treatment
A Prospective Clinical Trial of Radiation Therapy for Dupuytren's Contracture Following Surgical and Non-Surgical Release
This study is testing if targeted radiation therapy can help prevent Dupuytren's contracture from coming back after treatment in people aged 45 and older.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 95 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | Dartmouth-Hitchcock Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Lebanon, New Hampshire) |
| Trial ID | NCT06330545 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of targeted radiation therapy in preventing the recurrence of Dupuytren's contracture following a non-surgical release using Collagenase Clostridium Histolyticum. Participants aged 45 and older with advanced Dupuytren's contracture will receive radiation therapy for five days after their initial treatment, followed by a rest period and another five days of radiation. The study will monitor patients for any recurrence of contracture and assess the safety and tolerability of the combined treatment approach.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 45 or older with advanced Dupuytren's contracture who have undergone successful treatment with Collagenase Clostridium Histolyticum.
Not a fit: Patients who have had unsuccessful non-surgical release or those with certain chronic conditions affecting the hands may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the recurrence of Dupuytren's contracture, improving patients' hand function and quality of life.
How similar studies have performed: While the use of radiation therapy in this context is less common, similar approaches have shown promise in other conditions, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Lebanon, New Hampshire
- Dartmouth Hitchcock — Lebanon, New Hampshire, United States (Recruiting)
Study contacts
- Principal investigator: Lance Warhold, MD — Dartmouth Health
- Study coordinator: Julia S Schwarz, MD
- Email: julia.s.schwarz@hitchcock.org
- Phone: 603 650-5133
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.