Trials / Active Not Recruiting
Active Not RecruitingNCT03507010
Ledderhose Disease: Radiotherapy or Not?
Ledderhose Disease: Radiotherapy or Not? A Randomised, Multicentre, Prospective, Double Blind Phase III Trial Investigating the Effect of Radiotherapy on Patients With Ledderhose Disease
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 84 (actual)
- Sponsor
- University Medical Center Groningen · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim of the LedRad trial is to determine the efficacy and durability of radiotherapy as treatment for patients with Ledderhose disease and to compare this to the natural course of Ledderhose disease.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | Radiotherapy | Patients randomized to the Radiotherapy arm will be treated with electrons and receive a total dose of 30 Gy (two separate courses of five daily fractions of 3.0 Gy each). |
| OTHER | Sham Radiotherapy | Patients randomized to the sham-radiotherapy will not be treated and the radiotherapy treatment will only be simulated. |
Timeline
- Start date
- 2018-01-23
- Primary completion
- 2021-08-15
- Completion
- 2029-03-15
- First posted
- 2018-04-24
- Last updated
- 2024-02-28
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT03507010. Inclusion in this directory is not an endorsement.