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Completed

NCT Number: NCT04229147

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

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.

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Key information

Conditions

Ledderhose Disease Behavior Connective Tissue Diseases Contracture Fibroma Fibromatosis, Plantar Foot Diseases Muscular Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibrous Tissue Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Personal Satisfaction Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Groningen

Groningen, 9700RB, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiotherapy

Radiation

Patients who received a total dose of 30 Gy

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 18, 2020
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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