Ledderhose Disease: Radiotherapy or Not? (LedRad)

February 26, 2024 updated by: University Medical Center Groningen

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9700RB
        • University Medical Center Groningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radiotherapy
Patients assigned to the Radiotherapy group are treated with electrons and will receive a total dose of 30 Gy.
Radiation: Radiotherapy
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).
Placebo Comparator: Sham Radiotherapy
Patients assigned to the sham-radiotherapy group will not actually receive radiation. For these patients the radiation is simulated.
Other: Sham Radiotherapy
Patients randomized to the sham-radiotherapy will not be treated and the radiotherapy treatment will only be simulated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Rating Scale
Time Frame: 12 months
Determine pain with the Numeric Rating Scale
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Rating Scale
Time Frame: 6 and 18 months
Determine pain with the Numeric Rating Scale
6 and 18 months
Size of ledderhose nodules
Time Frame: 12 months
Determine the effect of radiotherapy on size of Ledderhose nodules with MRI and Ultrasound
12 months
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
6, 12 and 18 months
Walking motion
Time Frame: 12 months
Determine the effect of radiotherapy on walking motion with the PEDAR-X® in shoe pressure measurement system
12 months
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.
18 months
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
6, 12 and 18 months
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
6, 12 and 18 months
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
6, 12 and 18 months
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).
6, 12 and 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2018

Primary Completion (Actual)

August 15, 2021

Study Completion (Estimated)

March 15, 2029

Study Registration Dates

First Submitted

February 27, 2018

First Submitted That Met QC Criteria

April 13, 2018

First Posted (Actual)

April 24, 2018

Study Record Updates

Last Update Posted (Estimated)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RT2015-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ledderhose Disease

Clinical Trials on Radiotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe