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

Completed

• Conditions: Ledderhose Disease

• Registration Number: NCT04229147
• Lead Sponsor: University Medical Center Groningen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-13
• Study First Submitted: 2019-07-05
• Study First Submitted QC: 2020-01-10
• Study First Posted: 2020-01-18
• Primary Completion: 2020-01-31
• Study Completion: 2020-01-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current pain	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

Secondary Outcome Measures

Name	Time	Method
Worst pain	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
Late side effects of treatment	at least 2 years after treatment	Is treatment still effective and/or are there any (unknown) side effects of treatment
Satisfaction with radiotherapy treatment for Ledderhose disease	at least 2 years after treatment	Determine patient satisfaction with the radiotherapy treatment for Ledderhose disease using a self developed questionnaire
Quality of Life	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

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands