Clinical trial · Interventional
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
NCT03507010CI-TRIAL-00074421LedRadactive not recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ledderhose Disease | Plantar Fibromatosis | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy | Radiation | — | UNRESOLVED |
| Sham Radiotherapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Radiotherapy
- description
- Patients assigned to the Radiotherapy group are treated with electrons and will receive a total dose of 30 Gy.
- interventionNames
- Radiation: Radiotherapy
- type
- PLACEBO_COMPARATOR
- label
- Sham Radiotherapy
- description
- Patients assigned to the sham-radiotherapy group will not actually receive radiation. For these patients the radiation is simulated.
- interventionNames
- Other: Sham Radiotherapy
Primary outcomes (1)
- measure
- Numeric Rating Scale
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with painful Ledderhose disease. The pain score measured with the VAS score and is at least 2 on the 11-point scale (0 = no pain to 10 = worst imaginable pain). * Age ≥ 18 years * WHO performance status 0, 1 or 2 (Appendix, section 18) * Before patient randomisation, written informed consent must be given according to ICH/GCP, and WMO requirements. * Controlling the Dutch language (speaking and reading). * Able and willing to complete quality of life questionnaires in Dutch * Must be accessible for treatment follow-up Exclusion Criteria: * Surgical intervention before for Ledderhose disease * Previous radiation treatment for Ledderhose disease * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule * Not able to lay prone for at least fifteen minutes * Females who are pregnant at entry or who want to become pregnant within six months.
References
Publications (0)
Data not yet available
No reference posted for this study.