CClinicalTrials.gg
CompletedNCT04229147Updated Feb 28, 2024

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

An observational study in Ledderhose Disease, sponsored by University Medical Center Groningen. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-02-28.

Sponsored by University Medical Center Groningen · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
68
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Ledderhose Disease

Keywords

  • Radiotherapy
  • Pain
  • Side effect
  • Satisfaction
03

In context

Lead sponsor

University Medical Center Groningen is the lead sponsor of 609 studies on the registry; 174 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
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

Eligibility criteria

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

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
68 participants (actual)
Patient registry
No

Interventions

  • RadiationRadiotherapy

    Patients who received a total dose of 30 Gy

06

What researchers measure

Primary outcomes

  1. Current pain

    Determine pain with the numeric rating scale. A 11-point pain scale ranging from 0=no pain to 10=worst pain

    Time frame: at least 2 years after treatment

Secondary outcomes

  1. Worst pain

    Determine pain with the numeric rating scale. A 11-point pain scale ranging from 0=no pain to 10=worst pain

    Time frame: at least 2 years after treatment

  2. 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

    Time frame: at least 2 years after treatment

  3. Late side effects of treatment

    Is treatment still effective and/or are there any (unknown) side effects of treatment

    Time frame: at least 2 years after treatment

  4. Satisfaction with radiotherapy treatment for Ledderhose disease

    Determine patient satisfaction with the radiotherapy treatment for Ledderhose disease using a self developed questionnaire

    Time frame: at least 2 years after treatment

07

Study locations

1 site
  • University Medical Center Groningen
    Groningen, 9700RB, Netherlands
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04229147
Lead sponsor
University Medical Center Groningen
Responsible party
Sponsor
First posted
Jan 18, 2020
Start date
May 13, 2019
Primary completion
Jan 31, 2020
Completion
Jan 31, 2020
Last update
Feb 28, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion