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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04229147
Enrollment
68
Registered
2020-01-18
Start date
2019-05-13
Completion date
2020-01-31
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ledderhose Disease

Keywords

Radiotherapy, Pain, Side effect, Satisfaction

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.

Interventions

RADIATIONRadiotherapy

Patients who received a total dose of 30 Gy

Sponsors

University Medical Center Groningen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Current painat least 2 years after treatmentDetermine pain with the numeric rating scale. A 11-point pain scale ranging from 0=no pain to 10=worst pain

Secondary

MeasureTime frameDescription
Worst painat least 2 years after treatmentDetermine pain with the numeric rating scale. A 11-point pain scale ranging from 0=no pain to 10=worst pain
Quality of Lifeat least 2 years after treatmentAssess the impact on quality of life of the treatment with radiotherapy for this study population with the EURO-Qol-5D-5L
Late side effects of treatmentat least 2 years after treatmentIs treatment still effective and/or are there any (unknown) side effects of treatment
Satisfaction with radiotherapy treatment for Ledderhose diseaseat least 2 years after treatmentDetermine patient satisfaction with the radiotherapy treatment for Ledderhose disease using a self developed questionnaire

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026