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

Ledderhose Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04229147
• Other study ID #: RT2019-09
• Status: Completed
• Start date: May 13, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: February 2024
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years
• Eligibility: Patients treated with radiotherapy for Ledderhose disease at the UMCG at least 2 years ago

Related Conditions & MeSH terms

• Ledderhose Disease

Intervention

Radiation:
• Radiotherapy
Patients who received a total dose of 30 Gy

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Current pain	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	Worst pain	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	Quality of Life	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
Secondary	Late side effects of treatment	Is treatment still effective and/or are there any (unknown) side effects of treatment	at least 2 years after treatment
Secondary	Satisfaction with radiotherapy treatment for Ledderhose disease	Determine patient satisfaction with the radiotherapy treatment for Ledderhose disease using a self developed questionnaire	at least 2 years after treatment