Ledderhose DiseasePhase 3LedRadNCT03507010
Ledderhose Disease: Radiotherapy or Not?
A Phase 3 study testing Radiotherapy in people with Ledderhose Disease, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
The aim of the LedRad trial is to determine the efficacy and durability of radiotherapy as treatment for patients with Ledderhose disease and to compare this to the natural course of Ledderhose disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ledderhose Disease
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteNetherlands
- Study dates
- 23 Jan 2018to 15 Mar 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with painful Ledderhose disease. The pain score measured with the VAS score and is at least 2 on the 11-point scale (0 = no pain to 10 = worst imaginable pain).
- Age ≥ 18 years
- WHO performance status 0, 1 or 2 (Appendix, section 18)
- Before patient randomisation, written informed consent must be given according to ICH/GCP, and WMO requirements.
- Controlling the Dutch language (speaking and reading).
- Able and willing to complete quality of life questionnaires in Dutch
- Must be accessible for treatment follow-up
Who cannot join
- Surgical intervention before for Ledderhose disease
- Previous radiation treatment for Ledderhose disease
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Not able to lay prone for at least fifteen minutes
- Females who are pregnant at entry or who want to become pregnant within six months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ledderhose Disease: Radiotherapy or Not? A Randomised, Multicentre, Prospective, Double Blind Phase III Trial Investigating the Effect of Radiotherapy on Patients With Ledderhose Disease
The aim of the LedRad trial is to determine the efficacy and durability of radiotherapy as treatment for patients with Ledderhose disease and to compare this to the natural course of Ledderhose disease.
- Conditions
- Ledderhose Disease
- Being tested
- Radiotherapy, Sham Radiotherapy
- Keywords
- Radiotherapy, Pain
- Medical subject headings
- Fibromatosis, Plantar, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Patients randomized to the Radiotherapy arm will be treated with electrons and receive a total dose of 30 Gy (two separate courses of five daily fractions of 3.0 Gy each).
Sham RadiotherapyOther
Patients randomized to the sham-radiotherapy will not be treated and the radiotherapy treatment will only be simulated.
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy | Experimental | Patients assigned to the Radiotherapy group are treated with electrons and will receive a total dose of 30 Gy. Receives: Radiation: Radiotherapy |
| Sham Radiotherapy | Placebo comparator | Patients assigned to the sham-radiotherapy group will not actually receive radiation. For these patients the radiation is simulated. Receives: Other: Sham Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale
Determine pain with the Numeric Rating Scale
Measured: 12 months
Secondary outcomes (9)
Numeric Rating Scale
Determine pain with the Numeric Rating Scale
Measured: 6 and 18 months
Size of ledderhose nodules
Determine the effect of radiotherapy on size of Ledderhose nodules with MRI and Ultrasound
Measured: 12 months
Walking distance
Determine the effect of radiotherapy on walking distance with the 10 meter straight line walk test
Measured: 6, 12 and 18 months
Walking motion
Determine the effect of radiotherapy on walking motion with the PEDAR-X® in shoe pressure measurement system
Measured: 12 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Assess the safety and toxicity of radiotherapy on this population by recording the toxicity of radiotherapy during the course of radiotherapy and thereafter measured by CT-CAE 4.0.
Measured: 18 months
Quality of life (1)
Assess the impact on quality of life of radiotherapy as treatment for this study population with RAND-36 item Health Survey questionnaire
Measured: 6, 12 and 18 months
Quality of life (2)
Assess the impact on quality of life of radiotherapy as treatment for this study population with the brief pain inventory questionnaire
Measured: 6, 12 and 18 months
Quality of life (3)
Assess the impact on quality of life of radiotherapy as treatment for this study population with the EURO-Qol-5D questionnaire
Measured: 6, 12 and 18 months
Cost-effectiveness analysis (CEA)
The economic evaluation will be performed from a societal perspective, incorporating cost of travel to the hospital and cost of absence from work as well as direct medical cost of radiotherapy (cost of irradiation and outpatient visits). Questionnaires will be used to collect data regarding health care consumption, travel and time costs, and productivity loss at study entry and at 6-month intervals thereafter. In addition to the pain scores, quality of life will be assessed at 6-month intervals using the Rand-36 questionnaire. The utilities based on the results of the questionnaire will be used in a cost-utility analysis, calculating the ratio of incremental costs versus incremental quality-adjusted life-years (QALY).
Measured: 6, 12 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start23 Jan 2018
- Primary completion15 Aug 2021
- Study completion15 Mar 2029 (estimated)
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.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Catharina Ziekenhuis Eindhoven, Rijnstate Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03507010
- Sponsor's protocol ID
- RT2015-03
- Acronym
- LedRad
- Status last verified
- Feb 2024
- First submitted
- 27 Feb 2018
- 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: Radiotherapy or Not? A Randomised, Multicentre, Prospective, Double Blind Phase III Trial Investigating the Effect of Radiotherapy on Patients With Ledderhose Disease
- ClinicalTrials.gov ID
- NCT03507010
- Acronym / sponsor ID
- LedRad / RT2015-03
- Conditions
- Ledderhose Disease
- Keywords
- Radiotherapy, Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Catharina Ziekenhuis Eindhoven, Rijnstate Hospital
- Study start
- 23 Jan 2018 (actual)
- Primary completion
- 15 Aug 2021 (actual)
- Study completion
- 15 Mar 2029 (estimated)
- First posted
- 24 Apr 2018 (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 trial is to determine the efficacy and durability of radiotherapy as treatment for patients with Ledderhose disease and to compare this to the natural course of Ledderhose disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy | Experimental | Radiation: RadiotherapyPatients assigned to the Radiotherapy group are treated with electrons and will receive a total dose of 30 Gy. |
| Sham Radiotherapy | Placebo comparator | Other: Sham RadiotherapyPatients assigned to the sham-radiotherapy group will not actually receive radiation. For these patients the radiation is simulated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with painful Ledderhose disease. The pain score measured with the VAS score and is at least 2 on the 11-point scale (0 = no pain to 10 = worst imaginable pain).
- Age ≥ 18 years
- WHO performance status 0, 1 or 2 (Appendix, section 18)
- Before patient randomisation, written informed consent must be given according to ICH/GCP, and WMO requirements.
- Controlling the Dutch language (speaking and reading).
Key exclusion criteria (5 listed)
- Surgical intervention before for Ledderhose disease
- Previous radiation treatment for Ledderhose disease
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Not able to lay prone for at least fifteen minutes
- Females who are pregnant at entry or who want to become pregnant within six months.
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 randomized to the Radiotherapy arm will be treated with electrons and receive a total dose of 30 Gy (two separate courses of five daily fractions of 3.0 Gy each). | Radiation | Radiotherapy |
| Sham RadiotherapyPatients randomized to the sham-radiotherapy will not be treated and the radiotherapy treatment will only be simulated. | Other | Sham Radiotherapy |
Primary outcome
Numeric Rating Scale
Time frame: 12 months
Determine pain with the Numeric Rating Scale
9 secondary outcomes
Numeric Rating Scale
Time frame: 6 and 18 months
Size of ledderhose nodules
Time frame: 12 months
Walking distance
Time frame: 6, 12 and 18 months
Walking motion
Time frame: 12 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 18 months
Quality of life (1)
Time frame: 6, 12 and 18 months
Quality of life (2)
Time frame: 6, 12 and 18 months
Quality of life (3)
Time frame: 6, 12 and 18 months
Cost-effectiveness analysis (CEA)
Time frame: 6, 12 and 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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?
A Phase 3 study testing Radiotherapy in people with 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?
The sponsor lists 7 inclusion and 5 exclusion criteria. 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: under way, not looking for participants, 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Numeric Rating Scale (time frame: 12 months). 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.