Lower Limb LymphedemaEvaLymph-Leg1NCT05269264
Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Aim 1
An observational study of Lower Limb Lymphedema, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Of all of the different measurement methods that are currently available for use in clinical practice for assessing the same lymphedema characteristic (for example water displacement versus perimetry, both assessing swelling) or different lymphedema characteristics (for example water content in the skin versus… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lower Limb Lymphedema
- What is being tested?
- Assessor A (first measurement): measurement methods and questionnaires for the assessment of LLL, Assessor B: measurement methods and questionnaires for the assessment of LLL and Assessor A (second measurement: measurement methods and questionnaires for the assessment of LLL
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- 7 Feb 2022to Oct 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with unilateral or bilateral, primary or secondary LLL will be recruited in the center for lymphedema in UH Leuven. The healthy controls will be age, gender \& BMI matched subjects.
Who may be able to join
- Patient group
- Unilateral or bilateral, primary or secondary Lower limb lymphedema (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
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals of Leuven, center for lymphedema
Leuven, 3000
Nele Devoogdt, PhD, 0032 16 342515, nele.devoogdt@uzleuven.be
Tessa De Vrieze, PhD, 0032 16 34 50 06, tessa.devrieze@kuleuven.be
About this study
Official title: Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema (LLL): Reliability, Concurrent Validity and Clinical Feasibility of Currently Applied Measurement Tools in Patients With LLL
Of all of the different measurement methods that are currently available for use in clinical practice for assessing the same lymphedema characteristic (for example water displacement versus perimetry, both assessing swelling) or different lymphedema characteristics (for example water content in the skin versus hardness of the skin versus thickness of the skin), a clear overview about the reliability, concurrent validity (if applicable) and clinical feasibility is missing for the assessment of lower limb lymphedema (LLL).
The objective of this observational cross-sectional study is to investigate the (day-to-day) reliability and clinical feasibility of currently applied measurement tools in patients with LLL.
- Conditions
- Lower Limb Lymphedema
- Being tested
- Assessor A (first measurement): measurement methods and questionnaires for the assessment of LLL, Assessor B: measurement methods and questionnaires for the assessment of LLL, Assessor A (second measurement: measurement methods and questionnaires for the assessment of LLL, Assessor A (2 weeks later): measurement methods and questionnaires for the assessment of LLL
- Keywords
- Lymphedema, Measurement, Clinical evaluation, Reliability, Concurrent validity, Clinical feasibility, Lower limb
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessor A (first measurement): measurement methods and questionnaires for the assessment of LLLDiagnostic test
pitting test at the level of the foot, leg and midline region; skinfold test at the level of the foot, leg and midline region; skin hardness test at the level of the foot, leg and midline region; measurement with MoistureMeterD at the level of the foot, leg and midline region; measurement with SkinFibroMeter at the level of the foot, leg and midline region; circumference measurements at the level of the leg and midline region; perometry at the level of the leg; water displacement measurement at the level of the foot; measurements with bio-impedance spectroscopy/analysis devices at the level of the lower limbs and a questionnaire regarding skin integrity (ICC compression questionnaire) that should be completed by the therapist and a self-reported disease-specific quality of life questionnaire (Lymph-ICF-LL) that is completed by the patient at the end of this evaluation
Assessor B: measurement methods and questionnaires for the assessment of LLLDiagnostic test
pitting test at the level of the foot, leg and midline region; skinfold test at the level of the foot, leg and midline region; skin hardness test at the level of the foot, leg and midline region; measurement with MoistureMeterD at the level of the foot, leg and midline region; measurement with SkinFibroMeter at the level of the foot, leg and midline region; circumference measurements at the level of the leg and midline region; perometry at the level of the leg; water displacement measurement at the level of the foot; measurements with bio-impedance spectroscopy/analysis devices at the level of the lower limbs and a questionnaire regarding skin integrity (ICC compression questionnaire) that should be completed by the therapist
Assessor A (second measurement: measurement methods and questionnaires for the assessment of LLLDiagnostic test
pitting test at the level of the foot, leg and midline region; skinfold test at the level of the foot, leg and midline region; skin hardness test at the level of the foot, leg and midline region; measurement with MoistureMeterD at the level of the foot, leg and midline region; measurement with SkinFibroMeter at the level of the foot, leg and midline region; circumference measurements at the level of the leg and midline region; perometry at the level of the leg; water displacement measurement at the level of the foot; measurements with bio-impedance spectroscopy/analysis devices at the level of the lower limbs and a questionnaire regarding skin integrity (ICC compression questionnaire) that should be completed by the therapist
Assessor A (2 weeks later): measurement methods and questionnaires for the assessment of LLLDiagnostic test
pitting test at the level of the foot, leg and midline region; skinfold test at the level of the foot, leg and midline region; skin hardness test at the level of the foot, leg and midline region; measurement with MoistureMeterD at the level of the foot, leg and midline region; measurement with SkinFibroMeter at the level of the foot, leg and midline region; circumference measurements at the level of the leg and midline region; perometry at the level of the leg; water displacement measurement at the level of the foot; measurements with bio-impedance spectroscopy/analysis devices at the level of the lower limbs and a questionnaire regarding skin integrity (ICC compression questionnaire) that should be completed by the therapist and a self-reported disease-specific quality of life questionnaire (Lymph-ICF-LL) that is completed by the patient at the end of this evaluation
| Study group | Role | What they receive |
|---|---|---|
| patients with unilateral or bilateral, primary or secundary lower limb lymphedema (LLL) | patients with unilateral or bilateral, primary or secundary LLL who visit the center for lymphedema at UH Leuven Receives: Diagnostic Test: Assessor A (first measurement): measurement methods and questionnaires for the assessment of LLL; Diagnostic Test: Assessor B: measurement methods and questionnaires for the assessment of LLL; Diagnostic Test: Assessor A (second measurement: measurement methods and questionnaires for the assessment of LLL | |
| healthy controls | age, BMI and gender matched to the patients with LLL Receives: Diagnostic Test: Assessor A (first measurement): measurement methods and questionnaires for the assessment of LLL; Diagnostic Test: Assessor B: measurement methods and questionnaires for the assessment of LLL; Diagnostic Test: Assessor A (second measurement: measurement methods and questionnaires for the assessment of LLL | |
| subgroup (n=40) | a subgroup of subjects (patients \& healthy controls) will be evaluated again 2 weeks later Receives: Diagnostic Test: Assessor A (first measurement): measurement methods and questionnaires for the assessment of LLL; Diagnostic Test: Assessor B: measurement methods and questionnaires for the assessment of LLL; Diagnostic Test: Assessor A (second measurement: measurement methods and questionnaires for the assessment of LLL; Diagnostic Test: Assessor A (2 weeks later): measurement methods and questionnaires for the assessment of LLL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Within-session reliability of pitting test at the level of the foot, leg and midline region
intra and interrater reliability of 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: baseline (within-session)
Within-session reliability of skinfold test at the level of the foot, leg and midline region
intra and interrater reliability of 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: baseline (within-session)
Within-session reliability of skin hardness test at the level of the foot, leg and midline region
intra and interrater reliability 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: baseline (within-session)
Within-session reliability of measurement with MoistureMeterD at the level of the foot, leg and midline region
intra and interrater reliability of measurement with MoistureMeterD at the level of the foot, leg and midline region.
This device can be applied to measure the percentage of water under the skin in terms of the Tissue Dielectric Constant value, making use of a probe with 300 MHz signal. Up to a depth of 2.5mm, this portable device allows measuring free and bounded water in the tissue through which the electromagnetic wave passes.
Outcome: %PWC(% Percentage Water Content)
Measured: baseline (within-session)
Within-session reliability of measurement with SkinFibroMeter at the level of the foot, leg and midline region
intra and interrater reliability of measurement with SkinFibroMeter at the level of the foot, leg and midline region.
This device is a relatively recently developed device which consists of a 1-mm-long intender and records the resistance to 50 gram of pressure by using its reference plate and related built-in force sensors. Outcome: The resistance from the skin to deformation when an external force is applied, is expressed as a number in Newton (N) and represents the induration of the skin.
Measured: baseline (within-session)
Within-session reliability of circumference measurements at the level of the leg and midline region
intra and interrater reliability of circumference measurements at the level of the leg and midline region; Outcome: in cm for each of the tapeline, but a total volume can be calculated (in ml) using a truncated cone formula
Measured: baseline (within-session)
Within-session reliability of perometry at the level of the leg
intra and interrater reliability of perometry at the level of the leg; Optoelectronic volumetry (or perometry): a method that makes use of an optoelectronic infrared device to detect volume differences Outcome: in ml. The height of the measurement should be noted as well.
Measured: baseline (within-session)
Within-session reliability of water displacement measurement at the level of the foot
intra and interrater reliability of water displacement measurement at the level of the foot
Measured: baseline (within-session)
Within-session reliability of measurements with bio-impedance spectroscopy/analysis devices at the level of the lower limbs
intra and interrater reliability of measurements with bio-impedance spectroscopy/analysis devices at the level of the lower limbs
Measured: baseline (within-session)
Within-session reliability of a questionnaire regarding skin integrity
intra and interrater reliability of a questionnaire regarding skin integrity (ICC compression questionnaire) that should be completed by the therapist The ICC-CQ is the first reliable and valid questionnaire evaluating different kinds of compression and the experience by patients with lymphedema or chronic venous disease.
Measured: baseline (within-session)
Concurrent validity (only possible in case there are multiple measurement methods assessing the same lymphedema characteristic) of measurement methods for the assessment of LLL
the measurement methods assessing the same edema characteristic (for example: perometry and perimetry are two different methods that both evaluate lymphedema volume or swelling), will be correlated to each other
Measured: baseline (within-session)
Clinical feasibility of measurement methods and questionnaires for the assessment of Lower lymb lymphoedema
Time efficiency will be examined for each method (timed), limitations regarding clinical feasibility will be listed and scored for each method (present or absent). Finally, an overall ranking regarding feasibility score will be determined based on the reliability (best -> worse reliability) and time-efficiency (fastest -> slowest measurement method).
Measured: baseline (within-session)
Between-session reliability of 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) A cohort of patients with LLL (n= ±40) and healthy volunteers (±40) will be scheduled for a second visit, 2 weeks later for the same clinical evaluation (as at baseline), with only 1 assessor.
Measured: 2 weeks
Between-session reliability of 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)
A subgroup of patients with LLL (n= ±40) and healthy volunteers (±40) will be scheduled for a second visit, 2 weeks later for the same clinical evaluation (as at baseline), with only 1 assessor.
Measured: 2 weeks
Between-session reliability of 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)
A subgroup of patients with LLL (n= ±40) and healthy volunteers (±40) will be scheduled for a second visit, 2 weeks later for the same clinical evaluation (as at baseline), with only 1 assessor.
Measured: 2 weeks
Between-session reliability of measurement with MoistureMeterD at the level of the foot, leg and midline region
This device can be applied to measure the percentage of water under the skin in terms of the Tissue Dielectric Constant value, making use of a probe with 300 MHz signal. Up to a depth of 2.5mm, this portable device allows measuring free and bounded water in the tissue through which the electromagnetic wave passes.
Outcome: %PWC(% Percentage Water Content)
A subgroup of patients with LLL (n= ±40) and healthy volunteers (±40) will be scheduled for a second visit, 2 weeks later for the same clinical evaluation (as at baseline), with only 1 assessor.
Measured: 2 weeks
Between-session reliability of measurement with SkinFibroMeter at the level of the foot, leg and midline region
This device is a relatively recently developed device which consists of a 1-mm-long intender and records the resistance to 50 gram of pressure by using its reference plate and related built-in force sensors. Outcome: The resistance from the skin to deformation when an external force is applied, is expressed as a number in Newton (N) and represents the induration of the skin.
A subgroup of patients with LLL (n= ±40) and healthy volunteers (±40) will be scheduled for a second visit, 2 weeks later for the same clinical evaluation (as at baseline), with only 1 assessor.
Measured: 2 weeks
Between-session reliability of circumference measurements at the level of the leg and midline region
Circumference measurements (cm) with perimeter.
A subgroup of patients with LLL (n= ±40) and healthy volunteers (±40) will be scheduled for a second visit, 2 weeks later for the same clinical evaluation (as at baseline), with only 1 assessor.
Measured: 2 weeks
Between-session reliability of perometry at the level of the leg
Optoelectronic volumetry (or perometry): a method that makes use of an optoelectronic infrared device to detect volume differences Outcome: in ml. The height of the measurement should be noted as well.
A subgroup of patients with LLL (n= ±40) and healthy volunteers (±40) will be scheduled for a second visit, 2 weeks later for the same clinical evaluation (as at baseline), with only 1 assessor.
Measured: 2 weeks
Between-session reliability of water displacement measurement at the level of the foot
'Gold standard' in which the limb is immersed into a water tank and the weight of the limb is being weighted.
A subgroup of patients with LLL (n= ±40) and healthy volunteers (±40) will be scheduled for a second visit, 2 weeks later for the same clinical evaluation (as at baseline), with only 1 assessor.
Measured: 2 weeks
Between-session reliability of measurements with bio-impedance spectroscopy/analysis devices at the level of the lower limbs
Bio-impedance spectroscopy assesses the resistance (or impedance) to the flow of an electrical current that is primarily conducted by body fluid.
A subgroup of patients with LLL (n= ±40) and healthy volunteers (±40) will be scheduled for a second visit, 2 weeks later for the same clinical evaluation (as at baseline), with only 1 assessor.
Measured: 2 weeks
Between-session reliability of a questionnaire regarding skin integrity
Between-session reliability of a questionnaire regarding skin integrity: ICC compression questionnaire that should be completed by the therapist The ICC-CQ is the first reliable and valid questionnaire evaluating different kinds of compression and the experience by patients with lymphedema or chronic venous disease
Measured: 2 weeks
Between-session reliability of a self-reported disease-specific quality of life questionnaire (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: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start7 Feb 2022
- Primary completionSep 2025 (estimated)
- Study completionOct 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 Universitaire Ziekenhuizen 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
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
- Responsible party
- Sponsor
- Investigators
- Tessa De Vrieze, Dr., Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269264
- Sponsor's protocol ID
- s66033-aim1
- Acronym
- EvaLymph-Leg1
- Status last verified
- Jul 2024
- First submitted
- 8 Feb 2022
- Last updated
- 3 Jul 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 3 Jul 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 (LLL): Reliability, Concurrent Validity and Clinical Feasibility of Currently Applied Measurement Tools in Patients With LLL
- ClinicalTrials.gov ID
- NCT05269264
- Acronym / sponsor ID
- EvaLymph-Leg1 / s66033-aim1
- Conditions
- Lower Limb Lymphedema
- Keywords
- Lymphedema, Measurement, Clinical evaluation, Reliability, Concurrent validity, Clinical feasibility, Lower limb
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 7 Mar 2022 (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.
Of all of the different measurement methods that are currently available for use in clinical practice for assessing the same lymphedema characteristic (for example water displacement versus perimetry, both assessing swelling) or different lymphedema characteristics (for example water content in the skin versus hardness of the skin versus thickness of the skin), a clear overview about the reliability, concurrent validity (if applicable) and clinical feasibility is missing for the assessment of lower limb lymphedema (LLL).
The objective of this observational cross-sectional study is to investigate the (day-to-day) reliability and clinical feasibility of currently applied measurement tools in patients with LLL.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patients with unilateral or bilateral, primary or secundary lower limb lymphedema (LLL) | – | Diagnostic Test: Assessor A (first measurement): measurement methods and questionnaires for the assessment of LLL, Diagnostic Test: Assessor B: measurement methods and questionnaires for the assessment of LLL, Diagnostic Test: Assessor A (second measurement: measurement methods and questionnaires for the assessment of LLLpatients with unilateral or bilateral, primary or secundary LLL who visit the center for lymphedema at UH Leuven |
| healthy controls | – | Diagnostic Test: Assessor A (first measurement): measurement methods and questionnaires for the assessment of LLL, Diagnostic Test: Assessor B: measurement methods and questionnaires for the assessment of LLL, Diagnostic Test: Assessor A (second measurement: measurement methods and questionnaires for the assessment of LLLage, BMI and gender matched to the patients with LLL |
| subgroup (n=40) | – | Diagnostic Test: Assessor A (first measurement): measurement methods and questionnaires for the assessment of LLL, Diagnostic Test: Assessor B: measurement methods and questionnaires for the assessment of LLL, Diagnostic Test: Assessor A (second measurement: measurement methods and questionnaires for the assessment of LLL, Diagnostic Test: Assessor A (2 weeks later): measurement methods and questionnaires for the assessment of LLLa subgroup of subjects (patients \& healthy controls) will be evaluated again 2 weeks later |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with unilateral or bilateral, primary or secondary LLL will be recruited in the center for lymphedema in UH Leuven. The healthy controls will be age, gender \& BMI matched subjects.
Key inclusion criteria (7 listed)
- Patient group
- Unilateral or bilateral, primary or secondary Lower limb lymphedema (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 |
|---|---|---|
| Assessor A (first measurement): measurement methods and questionnaires for the assessment of LLLpitting test at the level of the foot, leg and midline region; skinfold test at the level of the foot, leg and midline region; skin hardness test at the level of the foot, leg and midline region; measurement with MoistureMeterD at the level of the foot, leg and midline region; measurement with SkinFibroMeter at the level of the foot, leg and midline region; circumference measurements at the level of the leg and midline region; perometry at the level of the leg; water displacement measurement at the level of the foot; measurements with bio-impedance spectroscopy/analysis devices at the level of the lower limbs and a questionnaire regarding skin integrity (ICC compression questionnaire) that should be completed by the therapist and a self-reported disease-specific quality of life questionnaire (Lymph-ICF-LL) that is completed by the patient at the end of this evaluation | Diagnostic test | healthy controls, patients with unilateral or bilateral, primary or secundary lower limb lymphedema (LLL), subgroup (n=40) |
| Assessor B: measurement methods and questionnaires for the assessment of LLLpitting test at the level of the foot, leg and midline region; skinfold test at the level of the foot, leg and midline region; skin hardness test at the level of the foot, leg and midline region; measurement with MoistureMeterD at the level of the foot, leg and midline region; measurement with SkinFibroMeter at the level of the foot, leg and midline region; circumference measurements at the level of the leg and midline region; perometry at the level of the leg; water displacement measurement at the level of the foot; measurements with bio-impedance spectroscopy/analysis devices at the level of the lower limbs and a questionnaire regarding skin integrity (ICC compression questionnaire) that should be completed by the therapist | Diagnostic test | healthy controls, patients with unilateral or bilateral, primary or secundary lower limb lymphedema (LLL), subgroup (n=40) |
| Assessor A (second measurement: measurement methods and questionnaires for the assessment of LLLpitting test at the level of the foot, leg and midline region; skinfold test at the level of the foot, leg and midline region; skin hardness test at the level of the foot, leg and midline region; measurement with MoistureMeterD at the level of the foot, leg and midline region; measurement with SkinFibroMeter at the level of the foot, leg and midline region; circumference measurements at the level of the leg and midline region; perometry at the level of the leg; water displacement measurement at the level of the foot; measurements with bio-impedance spectroscopy/analysis devices at the level of the lower limbs and a questionnaire regarding skin integrity (ICC compression questionnaire) that should be completed by the therapist | Diagnostic test | healthy controls, patients with unilateral or bilateral, primary or secundary lower limb lymphedema (LLL), subgroup (n=40) |
| Assessor A (2 weeks later): measurement methods and questionnaires for the assessment of LLLpitting test at the level of the foot, leg and midline region; skinfold test at the level of the foot, leg and midline region; skin hardness test at the level of the foot, leg and midline region; measurement with MoistureMeterD at the level of the foot, leg and midline region; measurement with SkinFibroMeter at the level of the foot, leg and midline region; circumference measurements at the level of the leg and midline region; perometry at the level of the leg; water displacement measurement at the level of the foot; measurements with bio-impedance spectroscopy/analysis devices at the level of the lower limbs and a questionnaire regarding skin integrity (ICC compression questionnaire) that should be completed by the therapist and a self-reported disease-specific quality of life questionnaire (Lymph-ICF-LL) that is completed by the patient at the end of this evaluation | Diagnostic test | subgroup (n=40) |
Primary outcome
Within-session reliability of pitting test at the level of the foot, leg and midline region
Time frame: baseline (within-session)
intra and interrater reliability of 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)
Within-session reliability of skinfold test at the level of the foot, leg and midline region
Time frame: baseline (within-session)
intra and interrater reliability of 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)
Within-session reliability of skin hardness test at the level of the foot, leg and midline region
Time frame: baseline (within-session)
intra and interrater reliability 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)
Within-session reliability of measurement with MoistureMeterD at the level of the foot, leg and midline region
Time frame: baseline (within-session)
intra and interrater reliability of measurement with MoistureMeterD at the level of the foot, leg and midline region. This device can be applied to measure the percentage of water under the skin in terms of the Tissue Dielectric Constant value, making use of a probe with 300 MHz signal. Up to a depth of 2.5mm, this portable device allows measuring free and bounded water in the tissue through which the electromagnetic wave passes. Outcome: %PWC(% Percentage Water Content)
Within-session reliability of measurement with SkinFibroMeter at the level of the foot, leg and midline region
Time frame: baseline (within-session)
intra and interrater reliability of measurement with SkinFibroMeter at the level of the foot, leg and midline region. This device is a relatively recently developed device which consists of a 1-mm-long intender and records the resistance to 50 gram of pressure by using its reference plate and related built-in force sensors. Outcome: The resistance from the skin to deformation when an external force is applied, is expressed as a number in Newton (N) and represents the induration of the skin.
Within-session reliability of circumference measurements at the level of the leg and midline region
Time frame: baseline (within-session)
intra and interrater reliability of circumference measurements at the level of the leg and midline region; Outcome: in cm for each of the tapeline, but a total volume can be calculated (in ml) using a truncated cone formula
Within-session reliability of perometry at the level of the leg
Time frame: baseline (within-session)
intra and interrater reliability of perometry at the level of the leg; Optoelectronic volumetry (or perometry): a method that makes use of an optoelectronic infrared device to detect volume differences Outcome: in ml. The height of the measurement should be noted as well.
Within-session reliability of water displacement measurement at the level of the foot
Time frame: baseline (within-session)
intra and interrater reliability of water displacement measurement at the level of the foot
Within-session reliability of measurements with bio-impedance spectroscopy/analysis devices at the level of the lower limbs
Time frame: baseline (within-session)
intra and interrater reliability of measurements with bio-impedance spectroscopy/analysis devices at the level of the lower limbs
Within-session reliability of a questionnaire regarding skin integrity
Time frame: baseline (within-session)
intra and interrater reliability of a questionnaire regarding skin integrity (ICC compression questionnaire) that should be completed by the therapist The ICC-CQ is the first reliable and valid questionnaire evaluating different kinds of compression and the experience by patients with lymphedema or chronic venous disease.
Concurrent validity (only possible in case there are multiple measurement methods assessing the same lymphedema characteristic) of measurement methods for the assessment of LLL
Time frame: baseline (within-session)
the measurement methods assessing the same edema characteristic (for example: perometry and perimetry are two different methods that both evaluate lymphedema volume or swelling), will be correlated to each other
Clinical feasibility of measurement methods and questionnaires for the assessment of Lower lymb lymphoedema
Time frame: baseline (within-session)
Time efficiency will be examined for each method (timed), limitations regarding clinical feasibility will be listed and scored for each method (present or absent). Finally, an overall ranking regarding feasibility score will be determined based on the reliability (best -> worse reliability) and time-efficiency (fastest -> slowest measurement method).
Between-session reliability of pitting test at the level of the foot, leg and midline region
Time frame: 2 weeks
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) A cohort of patients with LLL (n= ±40) and healthy volunteers (±40) will be scheduled for a second visit, 2 weeks later for the same clinical evaluation (as at baseline), with only 1 assessor.
Between-session reliability of skinfold test at the level of the foot, leg and midline region
Time frame: 2 weeks
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) A subgroup of patients with LLL (n= ±40) and healthy volunteers (±40) will be scheduled for a second visit, 2 weeks later for the same clinical evaluation (as at baseline), with only 1 assessor.
Between-session reliability of skin hardness test at the level of the foot, leg and midline region
Time frame: 2 weeks
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) A subgroup of patients with LLL (n= ±40) and healthy volunteers (±40) will be scheduled for a second visit, 2 weeks later for the same clinical evaluation (as at baseline), with only 1 assessor.
Between-session reliability of measurement with MoistureMeterD at the level of the foot, leg and midline region
Time frame: 2 weeks
This device can be applied to measure the percentage of water under the skin in terms of the Tissue Dielectric Constant value, making use of a probe with 300 MHz signal. Up to a depth of 2.5mm, this portable device allows measuring free and bounded water in the tissue through which the electromagnetic wave passes. Outcome: %PWC(% Percentage Water Content) A subgroup of patients with LLL (n= ±40) and healthy volunteers (±40) will be scheduled for a second visit, 2 weeks later for the same clinical evaluation (as at baseline), with only 1 assessor.
Between-session reliability of measurement with SkinFibroMeter at the level of the foot, leg and midline region
Time frame: 2 weeks
This device is a relatively recently developed device which consists of a 1-mm-long intender and records the resistance to 50 gram of pressure by using its reference plate and related built-in force sensors. Outcome: The resistance from the skin to deformation when an external force is applied, is expressed as a number in Newton (N) and represents the induration of the skin. A subgroup of patients with LLL (n= ±40) and healthy volunteers (±40) will be scheduled for a second visit, 2 weeks later for the same clinical evaluation (as at baseline), with only 1 assessor.
Between-session reliability of circumference measurements at the level of the leg and midline region
Time frame: 2 weeks
Circumference measurements (cm) with perimeter. A subgroup of patients with LLL (n= ±40) and healthy volunteers (±40) will be scheduled for a second visit, 2 weeks later for the same clinical evaluation (as at baseline), with only 1 assessor.
Between-session reliability of perometry at the level of the leg
Time frame: 2 weeks
Optoelectronic volumetry (or perometry): a method that makes use of an optoelectronic infrared device to detect volume differences Outcome: in ml. The height of the measurement should be noted as well. A subgroup of patients with LLL (n= ±40) and healthy volunteers (±40) will be scheduled for a second visit, 2 weeks later for the same clinical evaluation (as at baseline), with only 1 assessor.
Between-session reliability of water displacement measurement at the level of the foot
Time frame: 2 weeks
'Gold standard' in which the limb is immersed into a water tank and the weight of the limb is being weighted. A subgroup of patients with LLL (n= ±40) and healthy volunteers (±40) will be scheduled for a second visit, 2 weeks later for the same clinical evaluation (as at baseline), with only 1 assessor.
Between-session reliability of measurements with bio-impedance spectroscopy/analysis devices at the level of the lower limbs
Time frame: 2 weeks
Bio-impedance spectroscopy assesses the resistance (or impedance) to the flow of an electrical current that is primarily conducted by body fluid. A subgroup of patients with LLL (n= ±40) and healthy volunteers (±40) will be scheduled for a second visit, 2 weeks later for the same clinical evaluation (as at baseline), with only 1 assessor.
Between-session reliability of a questionnaire regarding skin integrity
Time frame: 2 weeks
Between-session reliability of a questionnaire regarding skin integrity: ICC compression questionnaire that should be completed by the therapist The ICC-CQ is the first reliable and valid questionnaire evaluating different kinds of compression and the experience by patients with lymphedema or chronic venous disease
Between-session reliability of a self-reported disease-specific quality of life questionnaire (Lymph-ICF-LL)
Time frame: 2 weeks
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
Related trials for Lower Limb Lymphedema
Recruiting
The Effect of Resistance Exercise in Patients With Lower Limb Lymphedema (the LymphEx Study)
Lymphedema
Recruiting
Extracorporeal Shock Wave Therapy in Lower Extremity Lymphedema
Lymphedema, Lower Limb, Extracorporeal Shock Wave Therapy
RecruitingEarly Phase 1
Evaluate Advanced Pneumatic Compression Device With Revised Compression Programming for Lymphedema Treatment
Lower Extremity Lymphedema
Not yet recruiting
Aerobic Exercise Effects in Lower Extremity Lymphedema
Lower Extremity Lymphedema
Recruiting
Boosted Compression for Lower Limb Chronic Edema
Chronic Edema, Lymphedema
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
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 Lower Limb Lymphedema, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 3 Jul 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 Belgium. 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?
Within-session reliability of pitting test at the level of the foot, leg and midline region (time frame: baseline (within-session)). The study lists 23 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 3 Jul 2024.