Lower Limb LymphedemaEvaLymph-Leg3NCT05757284
Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Aim 3
An observational study of Lower Limb Lymphedema, run by KU Leuven at 2 sites in 2 countries.
Trial summary
The current best practice is a three-stage classification consensus guideline as published by the International Society of Lymphology (ISL). Severity of lymphedema is however not only determined by presence of pitting (which is the phenomenon when the swollen area has a dimple (or pit) after you press it for 5 to 10… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Limb Lymphedema
- What is being tested?
- Lower Limb Lymhedema assessment
- How many people
- 140 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jan 2023to Oct 2024
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients with LLL will be recruited in the center for lymphedema in UH Leuven in Belgium and in the center for lymphedema in Nij Smellinghe Hospital in Drachten in the Netherlands. Healthy volunteers, both in Belgium as well as in the Netherlands.
Who may be able to join
- Patient group
- Unilateral or bilateral, primary or secondary LLL
- Objective diagnosis of lymphedema: ≥ 5% volume difference between both legs OR ≥ 2 minor/ 1 major criteria on lymphoscintigraphy OR presence of ICG dermal backflow
- Age ≥ 18 years
- Able to read, understand and speak Dutch
- Healthy controls
- Age, gender \& BMI-matched healthy controls
Who cannot join
- Pregnant participants
- Presence of chronic venous insufficiency C4, C5, C6; deep venous thrombosis; post-thrombotic syndrome
- Presence of skin infections of wounds at the level of the lower limbs at the moment of inclusion
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals of Leuven
Leuven, 3000
Tessa De Vrieze, Dr., 003216345006, tessa.devrieze@kuleuven.be
Netherlands1 site, 1 recruiting
- Not yet recruiting
Nij Smellinghe Hospital
Drachten, 9202
Ad Hendrickx, PhD, a.hendrickx@nijsmellinghe.nl
Robert Damstra, PhD, r.damstra@nijsmellinghe.nl
About this study
Official title: Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Development of a Diagnostic Set for Patients With LLL
The current best practice is a three-stage classification consensus guideline as published by the International Society of Lymphology (ISL). Severity of lymphedema is however not only determined by presence of pitting (which is the phenomenon when the swollen area has a dimple (or pit) after you press it for 5 to 10 seconds) and presence of adipose tissue or not, but is also determined by the volume of the edema, a quantification of the condition of the skin and the location/expansion of the edema over the body. Currently a severity score considering these different aspects does not exist. Although there is consensus that the ISL staging systems is a necessary part of the diagnosis of lymphedema, it gives not enough information about the severity of the lymphedema. A more detailed and comprehensive classification system applicable for primary and secondary lymphedema and considering multiple edema characteristics, remains to be formulated.
The researchers objective in this study is to develop a diagnostic set, including a 'severity score', for patients with LLL.
- Conditions
- Lower Limb Lymphedema
- Being tested
- Lower Limb Lymhedema assessment
- Keywords
- severity score, diagnostic set
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower Limb Lymhedema assessmentDiagnostic test
assessessment with the selected measurement methods showing sufficient reliability and feasibility in the patient group with LLL from aim 1:NCT05269264. Measurement will occur at the genital/midline region, and on both legs/ feet.
| Study group | Role | What they receive |
|---|---|---|
| patients with unilateral or bilateral, primary or secundary LLL | Not described Receives: Diagnostic Test: Lower Limb Lymhedema assessment | |
| healthy controls | Not described Receives: Diagnostic Test: Lower Limb Lymhedema assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of measurement methods (resulted from aim 1:NCT05269264) in diagnosing unilateral and bilateral LLL
all patients with LLL and all healthy controls will be assessed with the selected measurement methods showing sufficient reliability and feasibility in the patient group with LLL from aim 1. Measurement will occur at the genital/midline region, and on both legs/ feet.
Measured: During the recruitment period (up to 1 year), patients are scheduled for only 1 visit with duration of +/- 1 hour (cross-sectional design)
Specificity of measurement methods (resulted from aim 1:NCT05269264) in diagnosing unilateral and bilateral LLL
all patients with LLL and all healthy controls will be assessed with the selected measurement methods showing sufficient reliability and feasibility in the patient group with LLL from aim 1. Measurement will occur at the genital/midline region, and on both legs/ feet.
Measured: During the recruitment period (up to 1 year), patients are scheduled for only 1 visit with duration of +/- 1 hour (cross-sectional design)
Diagnostic accuracy of measurement methods (resulted from aim 1:NCT05269264) in diagnosing unilateral and bilateral LLL
all patients with LLL and all healthy controls will be assessed with the selected measurement: methods showing sufficient reliability and feasibility in the patient group with LLL from aim 1. Measurement will occur at the genital/midline region, and on both legs/ feet.
To determine diagnostic accuracy of the diagnostic methods, in a first phase, data will be analysed using Receiver Operating Characteristic (ROC) curves and by calculation the area under the curve (AUC) for each individual evaluation method resulting from aim 1.
Sensitivity and specificity values will be compared, and for each measurement method, the AUC (or C-statistic) will be considered. Also prognostic values and likelihood ratios will be calculated of the individual measurement methods.
Lastly, to investigate discriminant validity, measurement outcomes of the patients with LLL will be correlated to the measurement outcomes of the healthy controls.
Measured: During the recruitment period (up to 1 year), patients are scheduled for only 1 visit with duration of +/- 1 hour (cross-sectional design)
Development of a severity grading score for unilateral and bilateral LLL
a meeting with the international expert panel will be organized to achieve consensus regarding the measurement methods that should be performed to compile a severity score. Secondly, of all these separate measurement methods, percentiles (20, 40, 60, 80) will be calculated from the data of our study sample for this aim, serving as reference cut-off values. Consequently, 5 'severity' ranges will be presented that will correspond to a severity subscore between 0-5 for each measurement outcome. Lastly, a total severity score will be calculated
Measured: During the recruitment period (up to 1 year), patients are scheduled for only 1 visit with duration of +/- 1 hour (cross-sectional design)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start1 Jan 2023
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb LymphedemaStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven, Nij Smellinghe Hospital Drachten
- Responsible party
- Principal investigator, Tessa De Vrieze, KU Leuven
- Investigators
- Tessa De Vrieze, Dr., Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757284
- Sponsor's protocol ID
- s66033-aim3
- Acronym
- EvaLymph-Leg3
- Status last verified
- Mar 2024
- First submitted
- 7 Feb 2023
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Development of a Diagnostic Set for Patients With LLL
- ClinicalTrials.gov ID
- NCT05757284
- Acronym / sponsor ID
- EvaLymph-Leg3 / s66033-aim3
- Conditions
- Lower Limb Lymphedema
- Keywords
- severity score, diagnostic set
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven, Nij Smellinghe Hospital Drachten
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 7 Mar 2023 (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 current best practice is a three-stage classification consensus guideline as published by the International Society of Lymphology (ISL). Severity of lymphedema is however not only determined by presence of pitting (which is the phenomenon when the swollen area has a dimple (or pit) after you press it for 5 to 10 seconds) and presence of adipose tissue or not, but is also determined by the volume of the edema, a quantification of the condition of the skin and the location/expansion of the edema over the body. Currently a severity score considering these different aspects does not exist. Although there is consensus that the ISL staging systems is a necessary part of the diagnosis of lymphedema, it gives not enough information about the severity of the lymphedema. A more detailed and comprehensive classification system applicable for primary and secondary lymphedema and considering multiple edema characteristics, remains to be formulated.
The researchers objective in this study is to develop a diagnostic set, including a 'severity score', for patients with LLL.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with unilateral or bilateral, primary or secundary LLL | – | Diagnostic Test: Lower Limb Lymhedema assessment |
| healthy controls | – | Diagnostic Test: Lower Limb Lymhedema assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with LLL will be recruited in the center for lymphedema in UH Leuven in Belgium and in the center for lymphedema in Nij Smellinghe Hospital in Drachten in the Netherlands. Healthy volunteers, both in Belgium as well as in the Netherlands.
Key inclusion criteria (7 listed)
- Patient group
- Unilateral or bilateral, primary or secondary LLL
- Objective diagnosis of lymphedema: ≥ 5% volume difference between both legs OR ≥ 2 minor/ 1 major criteria on lymphoscintigraphy OR presence of ICG dermal backflow
- Age ≥ 18 years
- Able to read, understand and speak Dutch
Key exclusion criteria (3 listed)
- Pregnant participants
- Presence of chronic venous insufficiency C4, C5, C6; deep venous thrombosis; post-thrombotic syndrome
- Presence of skin infections of wounds at the level of the lower limbs at the moment of inclusion
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 |
|---|---|---|
| Lower Limb Lymhedema assessmentassessessment with the selected measurement methods showing sufficient reliability and feasibility in the patient group with LLL from aim 1:NCT05269264. Measurement will occur at the genital/midline region, and on both legs/ feet. | Diagnostic test | healthy controls, patients with unilateral or bilateral, primary or secundary LLL |
Primary outcome
Sensitivity of measurement methods (resulted from aim 1:NCT05269264) in diagnosing unilateral and bilateral LLL
Time frame: During the recruitment period (up to 1 year), patients are scheduled for only 1 visit with duration of +/- 1 hour (cross-sectional design)
all patients with LLL and all healthy controls will be assessed with the selected measurement methods showing sufficient reliability and feasibility in the patient group with LLL from aim 1. Measurement will occur at the genital/midline region, and on both legs/ feet.
Specificity of measurement methods (resulted from aim 1:NCT05269264) in diagnosing unilateral and bilateral LLL
Time frame: During the recruitment period (up to 1 year), patients are scheduled for only 1 visit with duration of +/- 1 hour (cross-sectional design)
all patients with LLL and all healthy controls will be assessed with the selected measurement methods showing sufficient reliability and feasibility in the patient group with LLL from aim 1. Measurement will occur at the genital/midline region, and on both legs/ feet.
Diagnostic accuracy of measurement methods (resulted from aim 1:NCT05269264) in diagnosing unilateral and bilateral LLL
Time frame: During the recruitment period (up to 1 year), patients are scheduled for only 1 visit with duration of +/- 1 hour (cross-sectional design)
all patients with LLL and all healthy controls will be assessed with the selected measurement: methods showing sufficient reliability and feasibility in the patient group with LLL from aim 1. Measurement will occur at the genital/midline region, and on both legs/ feet. To determine diagnostic accuracy of the diagnostic methods, in a first phase, data will be analysed using Receiver Operating Characteristic (ROC) curves and by calculation the area under the curve (AUC) for each individual evaluation method resulting from aim 1. Sensitivity and specificity values will be compared, and for each measurement method, the AUC (or C-statistic) will be considered. Also prognostic values and likelihood ratios will be calculated of the individual measurement methods. Lastly, to investigate discriminant validity, measurement outcomes of the patients with LLL will be correlated to the measurement outcomes of the healthy controls.
Development of a severity grading score for unilateral and bilateral LLL
Time frame: During the recruitment period (up to 1 year), patients are scheduled for only 1 visit with duration of +/- 1 hour (cross-sectional design)
a meeting with the international expert panel will be organized to achieve consensus regarding the measurement methods that should be performed to compile a severity score. Secondly, of all these separate measurement methods, percentiles (20, 40, 60, 80) will be calculated from the data of our study sample for this aim, serving as reference cut-off values. Consequently, 5 'severity' ranges will be presented that will correspond to a severity subscore between 0-5 for each measurement outcome. Lastly, a total severity score will be calculated
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
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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.
Tessa De Vrieze, Dr. principal investigator
KU Leuven
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Limb Lymphedema, run by KU Leuven at 2 sites in 2 countries.
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 3 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: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tessa De Vrieze, Dr. (003216345006, tessa.devrieze@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of measurement methods (resulted from aim 1:NCT05269264) in diagnosing unilateral and bilateral LLL (time frame: During the recruitment period (up to 1 year), patients are scheduled for only 1 visit with duration of +/- 1 hour (cross-sectional design)). The study lists 4 primary outcomes in all. 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 12 Mar 2024.