Trials / Recruiting
RecruitingNCT04122313
Post-contracture Release Radiation for Dupuytren's Disease
Efficacy of Post-contracture Release Radiation for the Treatment of Dupuytren's Disease
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 50 (estimated)
- Sponsor
- University of Minnesota · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To determine if the clinical impression of clinicians, ie that patients are improving with the current treatment pathway for Dupuytren's (contracture release followed by radiation), can be substantiated with scientific evidence.
Detailed description
This is an observational, pilot study. Participants will be treated according to a standard treatment pathway, which includes contracture release treatment modalities such as limited fasciectomy, PNA and CCH injection, followed by post-operative radiation. All enrolled participants will undergo radiation treatment as soon as possible following contracture release. Radiotherapy will consist of 5 daily treatments of 300 cGy delivered to the palmar area followed by a 6-8 weeks break then a second 5 day course of radiation at 300 cGy, for a total of 3000 cGy in 10 total fractions. This dosing schedule is commonly used in the published literature. The data to be collected about participants, is their Southampton Dupuytren's score, history and clinical symptoms and photographs of their hand. This information will be obtained at baseline (pre-surgical intervention), at radiation treatment planning, approximately 6 weeks after completion of all radiation and at 1 and 2 years following completion of radiotherapy.
Conditions
- Dupuytren's Disease
- Dupuytren Contracture
- Dupuytren Disease of Palm and Finger
- Dupuytren Disease of Finger
- Dupuytrens Contracture of Both Hands
- Dupuytren's Disease of Palm of Right Hand
- Dupuytren's Disease of Palm of Left Hand
- Dupuytren Contracture of Right Palm
- Dupuytren Contracture of Left Palm
- Dupuytren's Contracture Left
- Dupuytren's Contracture Right
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Evaluation of Dupuytren's Disease Treatment | There are no study interventions. The study interaction will be asking the patients to complete an additional outcome questionnaire and allow a medical record review. |
Timeline
- Start date
- 2019-05-31
- Primary completion
- 2029-03-01
- Completion
- 2029-03-01
- First posted
- 2019-10-10
- Last updated
- 2026-03-19
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04122313. Inclusion in this directory is not an endorsement.