Ledderhose Disease: Radiotherapy or Not? (LedRad)

University Medical Center Groningen (UMCG)

Status and phase: Active, not recruiting; Phase 3

Conditions: Ledderhose Disease

Treatments: Other: Sham Radiotherapy; Radiation: Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03507010

RT2015-03

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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84 participants in 2 patient groups, including a placebo group

Radiotherapy

Experimental group

Description:

Patients assigned to the Radiotherapy group are treated with electrons and will receive a total dose of 30 Gy.

Treatment:

Radiation: Radiotherapy

Sham Radiotherapy

Placebo Comparator group

Description:

Patients assigned to the sham-radiotherapy group will not actually receive radiation. For these patients the radiation is simulated.

Treatment:

Other: Sham Radiotherapy