Ledderhose DiseaseNCT04229147
Ledderhose Disease - Long Term Effects of Radiotherapy Treatment. LedRad LTE - Study
An observational study of Ledderhose Disease, run by University Medical Center Groningen at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ledderhose Disease
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 68 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 May 2019to 31 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Ledderhose disease and treated with radiotherapy at least 2 years ago at the UMCG
Patients treated with radiotherapy for Ledderhose disease at the UMCG at least 2 years ago
Trial locations and contacts
1 site in 1 country.
About this 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.
- Conditions
- Ledderhose Disease
- Being tested
- Radiotherapy
- Keywords
- Radiotherapy, Pain, Side effect, Satisfaction
- Medical subject headings
- Fibromatosis, Plantar, Pain, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Patients who received a total dose of 30 Gy
What is being measured
The primary outcome is the main question the study is designed to answer.
Current pain
Determine pain with the numeric rating scale. A 11-point pain scale ranging from 0=no pain to 10=worst pain
Measured: at least 2 years after treatment
Secondary outcomes (4)
Worst pain
Determine pain with the numeric rating scale. A 11-point pain scale ranging from 0=no pain to 10=worst pain
Measured: at least 2 years after treatment
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
Measured: at least 2 years after treatment
Late side effects of treatment
Is treatment still effective and/or are there any (unknown) side effects of treatment
Measured: at least 2 years after treatment
Satisfaction with radiotherapy treatment for Ledderhose disease
Determine patient satisfaction with the radiotherapy treatment for Ledderhose disease using a self developed questionnaire
Measured: at least 2 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start13 May 2019
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ledderhose DiseaseStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04229147
- Sponsor's protocol ID
- RT2019-09
- Status last verified
- Feb 2024
- First submitted
- 5 Jul 2019
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ledderhose Disease - Long Term Effects of Radiotherapy Treatment. LedRad LTE - Study
- ClinicalTrials.gov ID
- NCT04229147
- Acronym / sponsor ID
- RT2019-09
- Conditions
- Ledderhose Disease
- Keywords
- Radiotherapy, Pain, Side effect, Satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 13 May 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Ledderhose disease and treated with radiotherapy at least 2 years ago at the UMCG
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiotherapyPatients who received a total dose of 30 Gy | Radiation | – |
Primary outcome
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
4 secondary outcomes
Worst pain
Time frame: at least 2 years after treatment
Quality of Life
Time frame: at least 2 years after treatment
Late side effects of treatment
Time frame: at least 2 years after treatment
Satisfaction with radiotherapy treatment for Ledderhose disease
Time frame: at least 2 years after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Ledderhose Disease
Active, not recruitingPhase 3
Ledderhose Disease: Radiotherapy or Not?
Ledderhose Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ledderhose Disease, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Current pain (time frame: at least 2 years after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.