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Ledderhose Disease: Radiotherapy or Not?

NCT03507010 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2024-02-28

No results posted yet for this study

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

  • Ledderhose Disease

Interventions

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.

Sponsors & Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    collaborator OTHER

  • Catharina Ziekenhuis Eindhoven

    collaborator OTHER

  • Rijnstate Hospital

    collaborator OTHER

  • University Medical Center Groningen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-23
Primary Completion
2021-08-15
Completion
2029-03-15

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03507010 on ClinicalTrials.gov