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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 45 Years and Over
Gender All
More 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06330545
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Dartmouth-Hitchcock Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Lance Warhold, MD
Principal Investigator Affiliation Dartmouth Health
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Dupuytren Contracture
Additional Details

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.

Arms & Interventions

Arms

Experimental: Patients with Dupuytren's Contacture

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.

Interventions

Radiation: - Radiation therapy

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Dartmouth Hitchcock, Lebanon, New Hampshire

Status

Recruiting

Address

Dartmouth Hitchcock

Lebanon, New Hampshire, 03766

Site Contact

Julia Schwarz, MD

[email protected]

6036505133

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