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OpenTrials
Active, Not Recruiting

NCT Number: NCT03507010

Ledderhose Disease: Radiotherapy or Not?

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Ledderhose Disease Connective Tissue Diseases Contracture Fibroma Fibromatosis, Plantar Foot Diseases Muscular Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibrous Tissue Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Medical Center Groningen

Groningen, 9700RB, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Radiotherapy

Radiation

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).

Sham Radiotherapy

Other

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

Primary outcomes

  1. Numeric Rating Scale

    Time frame: 12 months

    Determine pain with the Numeric Rating Scale

Secondary outcomes

  1. Numeric Rating Scale

    Time frame: 6 and 18 months

    Determine pain with the Numeric Rating Scale

  2. Size of ledderhose nodules

    Time frame: 12 months

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

  3. Walking distance

    Time frame: 6, 12 and 18 months

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

  4. Walking motion

    Time frame: 12 months

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

  5. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: 18 months

    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.

  6. Quality of life (1)

    Time frame: 6, 12 and 18 months

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

  7. Quality of life (2)

    Time frame: 6, 12 and 18 months

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

  8. Quality of life (3)

    Time frame: 6, 12 and 18 months

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

  9. Cost-effectiveness analysis (CEA)

    Time frame: 6, 12 and 18 months

    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).

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Catharina Ziekenhuis Eindhoven
  • Rijnstate Hospital

Registry information

Official study title

Ledderhose Disease: Radiotherapy or Not? A Randomised, Multicentre, Prospective, Double Blind Phase III Trial Investigating the Effect of Radiotherapy on Patients With Ledderhose Disease

Acronym: LedRad

Important dates

Study start
2018
Primary completion
2021
Study completion
2029
First posted
Apr 24, 2018
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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