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

February 26, 2024 updated by: University Medical Center Groningen
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

68

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with Ledderhose disease and treated with radiotherapy at least 2 years ago at the UMCG

Description

Patients treated with radiotherapy for Ledderhose disease at the UMCG at least 2 years ago

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

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Current pain
Time Frame: at least 2 years after treatment
Determine pain with the numeric rating scale. A 11-point pain scale ranging from 0=no pain to 10=worst pain
at least 2 years after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Worst pain
Time Frame: at least 2 years after treatment
Determine pain with the numeric rating scale. A 11-point pain scale ranging from 0=no pain to 10=worst pain
at least 2 years after treatment
Quality of Life
Time Frame: at least 2 years after treatment
Assess the impact on quality of life of the treatment with radiotherapy for this study population with the EURO-Qol-5D-5L
at least 2 years after treatment
Late side effects of treatment
Time Frame: at least 2 years after treatment
Is treatment still effective and/or are there any (unknown) side effects of treatment
at least 2 years after treatment
Satisfaction with radiotherapy treatment for Ledderhose disease
Time Frame: at least 2 years after treatment
Determine patient satisfaction with the radiotherapy treatment for Ledderhose disease using a self developed questionnaire
at least 2 years after treatment

Collaborators and Investigators

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

Sponsor

University Medical Center Groningen

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)

May 13, 2019

Primary Completion (Actual)

January 31, 2020

Study Completion (Actual)

January 31, 2020

Study Registration Dates

First Submitted

July 5, 2019

First Submitted That Met QC Criteria

January 10, 2020

First Posted (Actual)

January 18, 2020

Study Record Updates

Last Update Posted (Actual)

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

  • RT2019-09

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.

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