Lower Limb LymphedemaEvaLymph-Leg4NCT06038864
Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Aim 4
An observational study of Lower Limb Lymphedema, run by KU Leuven at 2 sites in 2 countries.
Trial summary
Research investigating measurement properties for evaluating the decongestive treatment effect on different edema characteristics (e.g. water volume, hardness of the skin, water content,..) at the level of the lower limbs is missing. 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?
- 2 clinical evaluations with 1 month in between
- How many people
- 120 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Apr 2024to 1 Dec 2025
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Intensive treatment group: Patients planned to start with intensive decongestive lymphatic therapy at one or both legs. Maintenance treatment group: patienst who have ended their intensive treatment phase at least 3 months ago (= currently receiving maintenance decongestive lymphatic therapy)
Who may be able to join
- Intensive treatment group
- Unilateral or bilateral, primary or secondary LLL
- No active metastases
- If cancer-related lymphedema, time interval since surgery/ radiotherapy/ chemotherapy is ≥3 months
- Objective diagnosis of lymphedema: ≥ 5% volume difference OR ≥ 2 minor/ 1 major criteria on lymphoscintigraphy OR presence of ICG dermal backflow
- Age ≥ 18 years
Show all 11Show fewer
- Able to read, understand and speak Dutch
- Planned to start with intensive decongestive lymphatic therapy at one or both legs
- Maintenance treatment group
- See inclusion criteria 'intensive treatment group'
- But: instead of patients planned to start with intensive lymphatic therapy, patients of this group should have ended their intensive treatment phase at least 3 months ago (= currently receiving maintenance decongestive lymphatic therapy)
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 an Evaluation Set for Patients With LLL
Research investigating measurement properties for evaluating the decongestive treatment effect on different edema characteristics (e.g. water volume, hardness of the skin, water content,..) at the level of the lower limbs is missing. Information about the clinical relevant change criteria after treatment for nearly all these edema characteristics, is not present and requires investigation.
To assess the merits of each treatment in a reproducible manner, a reliable way of measuring limb volume and other edema characteristics must be established, as the evaluation of treatment effects without appropriate tools might lead to biased treatment effects.
Read more
First of all, in clinical practice, it is of utmost importance to know which edema characteristics need to be evaluated in order to assess the clinical evolution of a patient with lymphedema during and after treatment. Secondly, in order to draw proper conclusions about the treatment effect, it is necessary that to know from which criterion (or cut-off value) one can speak of a real clinical change for a certain lymphedema characteristic. Given that the edema characteristics that are most responsive to treatment and their corresponding criteria for clinically significant and relevant changes at the lower limbs have never been investigated before, the need for this research is high.
Therefore, the research questions in this study are: Which measurement tool(s) are able to detect clinically relevant changes in the lymphedema characteristics after the intensive treatment and during the maintenance treatment? When can a clinician speak of a clinically relevant change?
- Conditions
- Lower Limb Lymphedema
- Being tested
- 2 clinical evaluations with 1 month in between
- Keywords
- lymphedema, measurement, clinical evaluation
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 clinical evaluations with 1 month in betweenDiagnostic test
Patients will be evaluated twice with all evaluation methods selected by the international expert group (cfr. aim 1) showing sufficient reliability and feasibility in the patient group with LLL from aim 1
| Study group | Role | What they receive |
|---|---|---|
| Intensive group | Patients with lower limb lymphoedema planned for intensive treatment Receives: Diagnostic Test: 2 clinical evaluations with 1 month in between | |
| Maintenance group | Patients with stable lower limb lymphoedema who are in the maintenance phase (at least 3 months) Receives: Diagnostic Test: 2 clinical evaluations with 1 month in between |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of measurement methods
Sensitivity of measurement methods (resulting from aim 1:NCT05269264) in the evaluation of the treatment effect over time in patients with unilateral and bilateral LLL.
Patients will be evaluated twice with 1 month in between.
Measured: 1 month
Specificity of measurement methods
Specificity of measurement methods (resulting from aim 1:NCT05269264) in the evaluation of the treatment effect over time in patients with unilateral and bilateral LLL.
Patients will be evaluated twice with 1 month in between.
Measured: 1 month
Diagnostic accuracy of measurement methods
Diagnostic accuracy (in terms of area under the curve using a ROC curve, as well as sensitivity and specificity) of measurement methods (resulting from aim 1:NCT05269264) in the evaluation of the treatment effect over time in patients with unilateral and bilateral LLL.
Patients will be evaluated twice with 1 month in between.
Measured: 1 month
Secondary outcomes (6)
Lymphedema volume after 4 weeks of intensive DLT in patients with unilateral and bilateral LLL
Evaluation of different outcome parameters in the patients from the 'intensive group' with unilateral LLL and patients with bilateral LLL:
Lymphedema volume (foot, leg)
Measured: 1 month
Hardness of skin after 4 weeks of intensive DLT in patients with unilateral and bilateral LLL
Evaluation of different outcome parameters in the patients from the 'intensive group' with unilateral LLL and patients with bilateral LLL:
skin hardness test at the level of the foot, leg and midline region. Skin is palpated with thumb and index (and, if possible, compared to the contralateral side) Outcome: If skin is hardened; yes(1), otherwise; no(0)
Measured: 1 month
Piiting status after 4 weeks f intensive DLT in patients with unilateral and bilateral LLL
Evaluation of different outcome parameters in the patients from the 'intensive group' with unilateral LLL and patients with bilateral LLL:
Pitting test at the level of the foot, leg and midline region;
The grading of edema is determined by pit depth (measured visually) and recovery time from grade 0-3. The scale is used to rate the severity and the scores are as follows:
- Grade 0: No clinical edema- Grade 1: Slight pitting (up to 2 mm depth) - Grade 2: Moderate pitting (2-5 mm) - Grade 3: Noticeably deep pit (>5 mm)
Measured: 1 month
Skinfold thickness after 4 weeks of intensive DLT in patients with unilateral and bilateral LLL
Evaluation of different outcome parameters in the patients from the 'intensive group' with unilateral LLL and patients with bilateral LLL:
Skinfold test at the level of the foot, leg and midline region:
Skin and subcutaneous tissue is lifted between thumb and index(and, if possible, compared to the contralateral side) Outcome:If skinfold is increased; yes(1), otherwise; no(0)
Measured: 1 month
Extracellullar fluid after 4 weeks of intensive DLT in patients with unilateral and bilateral LLL
Evaluation of different outcome parameters (ECW ratio, total body water, body water left/right leg, ICW total/left/right, ECW total/left/right, phase angle total/left/right, impedance at 5 kHz) in the patients from the 'intensive group' with unilateral LLL and patients with bilateral LLL:
Extracellular fluid
Measured: 1 month
Problems in functioning after 4 weeks of intensive DLT in patients with unilateral and bilateral LLL
Disease-specific QoL (i.e. problems in functioning will be evaluated with the Lymph-ICF-LL.
The Lymph-ICF-LL is a descriptive, evaluative tool containing 28 questions about impairments in function, activity limitations, and participation restrictions in patients with lower limb lymphedema. The questionnaire has 5 domains: physical function, mental function, general tasks/household activities, mobility activities, and life domains/social life.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start1 Apr 2024
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Dec 2025 (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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 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
- NCT06038864
- Sponsor's protocol ID
- s66033-aim4
- Acronym
- EvaLymph-Leg4
- Status last verified
- Sep 2024
- First submitted
- 4 Sep 2023
- Last updated
- 19 Sep 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 19 Sep 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 an Evaluation Set for Patients With LLL
- ClinicalTrials.gov ID
- NCT06038864
- Acronym / sponsor ID
- EvaLymph-Leg4 / s66033-aim4
- Conditions
- Lower Limb Lymphedema
- Keywords
- lymphedema, measurement, clinical evaluation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven, Nij Smellinghe Hospital Drachten
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 15 Sep 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.
Research investigating measurement properties for evaluating the decongestive treatment effect on different edema characteristics (e.g. water volume, hardness of the skin, water content,..) at the level of the lower limbs is missing. Information about the clinical relevant change criteria after treatment for nearly all these edema characteristics, is not present and requires investigation.
To assess the merits of each treatment in a reproducible manner, a reliable way of measuring limb volume and other edema characteristics must be established, as the evaluation of treatment effects without appropriate tools might lead to biased treatment effects.
First of all, in clinical practice, it is of utmost importance to know which edema characteristics need to be evaluated in order to assess the clinical evolution of a patient with lymphedema during and after treatment. Secondly, in order to draw proper conclusions about the treatment effect, it is necessary that to know from which criterion (or cut-off value) one can speak of a real clinical change for a certain lymphedema characteristic. Given that the edema characteristics that are most responsive to treatment and their corresponding criteria for clinically significant and relevant changes at the lower limbs have never been investigated before, the need for this research is high.
Therefore, the research questions in this study are: Which measurement tool(s) are able to detect clinically relevant changes in the lymphedema characteristics after the intensive treatment and during the maintenance treatment? When can a clinician speak of a clinically relevant change?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive group | – | Diagnostic Test: 2 clinical evaluations with 1 month in betweenPatients with lower limb lymphoedema planned for intensive treatment |
| Maintenance group | – | Diagnostic Test: 2 clinical evaluations with 1 month in betweenPatients with stable lower limb lymphoedema who are in the maintenance phase (at least 3 months) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intensive treatment group: Patients planned to start with intensive decongestive lymphatic therapy at one or both legs. Maintenance treatment group: patienst who have ended their intensive treatment phase at least 3 months ago (= currently receiving maintenance decongestive lymphatic therapy)
Key inclusion criteria (11 listed)
- Intensive treatment group
- Maintenance treatment group
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 |
|---|---|---|
| 2 clinical evaluations with 1 month in betweenPatients will be evaluated twice with all evaluation methods selected by the international expert group (cfr. aim 1) showing sufficient reliability and feasibility in the patient group with LLL from aim 1 | Diagnostic test | Intensive group, Maintenance group |
Primary outcome
Sensitivity of measurement methods
Time frame: 1 month
Sensitivity of measurement methods (resulting from aim 1:NCT05269264) in the evaluation of the treatment effect over time in patients with unilateral and bilateral LLL. Patients will be evaluated twice with 1 month in between.
Specificity of measurement methods
Time frame: 1 month
Specificity of measurement methods (resulting from aim 1:NCT05269264) in the evaluation of the treatment effect over time in patients with unilateral and bilateral LLL. Patients will be evaluated twice with 1 month in between.
Diagnostic accuracy of measurement methods
Time frame: 1 month
Diagnostic accuracy (in terms of area under the curve using a ROC curve, as well as sensitivity and specificity) of measurement methods (resulting from aim 1:NCT05269264) in the evaluation of the treatment effect over time in patients with unilateral and bilateral LLL. Patients will be evaluated twice with 1 month in between.
6 secondary outcomes
Lymphedema volume after 4 weeks of intensive DLT in patients with unilateral and bilateral LLL
Time frame: 1 month
Hardness of skin after 4 weeks of intensive DLT in patients with unilateral and bilateral LLL
Time frame: 1 month
Piiting status after 4 weeks f intensive DLT in patients with unilateral and bilateral LLL
Time frame: 1 month
Skinfold thickness after 4 weeks of intensive DLT in patients with unilateral and bilateral LLL
Time frame: 1 month
Extracellullar fluid after 4 weeks of intensive DLT in patients with unilateral and bilateral LLL
Time frame: 1 month
Problems in functioning after 4 weeks of intensive DLT in patients with unilateral and bilateral LLL
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 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 11 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 19 Sep 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 (time frame: 1 month). The study lists 3 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 19 Sep 2024.