Symptoms and General Pathology

All Conditions

Neoplasms

Musculoskeletal Diseases

Skin and Connective Tissue Diseases

Nervous System Diseases

Rare Diseases

Pain

Fibromatosis, Plantar

Fibroma

Neoplasms, Fibrous Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Foot Diseases

Contracture

Muscular Diseases

Connective Tissue Diseases

Skin Diseases

Ledderhose Disease

Patients who received a total dose of 30 Gy

Radiotherapy

The aim of the LedRad LTE study is to determine the current complaints, late side effects and satisfaction of patients who were treated with radiotherapy for Ledderhose disease at least two years ago.

Ledderhose Disease - Long Term Effects of Radiotherapy Treatment. LedRad LTE - Study

Determine pain with the numeric rating scale. A 11-point pain scale ranging from 0=no pain to 10=worst pain

Assess the impact on quality of life of the treatment with radiotherapy for this study population with the EURO-Qol-5D-5L

Is treatment still effective and/or are there any (unknown) side effects of treatment

Determine patient satisfaction with the radiotherapy treatment for Ledderhose disease using a self developed questionnaire

University Medical Center Groningen

EN3835

Placebo

Clinical Operations

Luis Ortega

This study will assess the efficacy, safety, and tolerability of EN3835 compared to placebo in the treatment of PFI (also known as Ledderhose disease).

Study to Assess EN3835 in the Treatment of Plantar Fibromatosis (Also Known as Ledderhose Disease)

A Phase 3, Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of EN3835 vs Placebo in the Treatment of Plantar Fibromatosis (PFI) (Also Known as Ledderhose Disease)

Endo Pharmaceuticals

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

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

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).

Patients randomized to the sham-radiotherapy will not be treated and the radiotherapy treatment will only be simulated.

Sham Radiotherapy

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.

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

Determine pain with the Numeric Rating Scale

Determine the effect of radiotherapy on size of Ledderhose nodules with MRI and Ultrasound

Determine the effect of radiotherapy on walking distance with the 10 meter straight line walk test

Determine the effect of radiotherapy on walking motion with the PEDAR-X® in shoe pressure measurement system

Assess the safety and toxicity of radiotherapy on this population by recording the toxicity of radiotherapy during the course of radiotherapy and thereafter measured by CT-CAE 4.0.

Assess the impact on quality of life of radiotherapy as treatment for this study population with RAND-36 item Health Survey questionnaire

Assess the impact on quality of life of radiotherapy as treatment for this study population with the brief pain inventory questionnaire

Assess the impact on quality of life of radiotherapy as treatment for this study population with the EURO-Qol-5D questionnaire

The economic evaluation will be performed from a societal perspective, incorporating cost of travel to the hospital and cost of absence from work as well as direct medical cost of radiotherapy (cost of irradiation and outpatient visits). Questionnaires will be used to collect data regarding health care consumption, travel and time costs, and productivity loss at study entry and at 6-month intervals thereafter. In addition to the pain scores, quality of life will be assessed at 6-month intervals using the Rand-36 questionnaire. The utilities based on the results of the questionnaire will be used in a cost-utility analysis, calculating the ratio of incremental costs versus incremental quality-adjusted life-years (QALY).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ledderhose Disease - Long Term Effects of Radiotherapy Treatment. LedRad LTE - Study	NCT04229147	Ledderhose Dise...	Radiotherapy	18 Years - 90 Years	University Medical Center Groningen
Study to Assess EN3835 in the Treatment of Plantar Fibromatosis (Also Known as Ledderhose Disease)	NCT06151197	Plantar Fibroma... Ledderhose Dise...	EN3835 Placebo	18 Years -	Endo Pharmaceuticals
Ledderhose Disease: Radiotherapy or Not?	NCT03507010	Ledderhose Dise...	Radiotherapy Sham Radiothera...	18 Years -	University Medical Center Groningen

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