Ledderhose Disease: Radiotherapy or Not? (NCT03507010) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Ledderhose Disease: Radiotherapy or Not?
Netherlands84 participantsStarted 2018-01-23
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.