Brief 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 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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

200

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Feb 2022

Typical duration for all trials

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3.6 years study duration

Study Start

First participant enrolled

February 7, 2022

Completed

1 day until next milestone

First Submitted

Initial submission to the registry

February 8, 2022

Completed

27 days until next milestone

First Posted

Study publicly available on registry

March 7, 2022

Completed

3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed

Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

3.6 years

First QC Date

February 8, 2022

Last Update Submit

July 1, 2024

Conditions

Lower Limb Lymphedema

Keywords

LymphedemaMeasurementClinical evaluationReliabilityConcurrent validityClinical feasibilityLower limb

Outcome Measures

Primary Outcomes (23)

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)
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)
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)
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)
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.
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
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.
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
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
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.
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
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
2 weeks

Study Arms (3)

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

Diagnostic Test: Assessor A (first measurement): measurement methods and questionnaires for the assessment of LLLDiagnostic Test: Assessor B: measurement methods and questionnaires for the assessment of LLLDiagnostic 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

subgroup (n=40)

a subgroup of subjects (patients \& healthy controls) will be evaluated again 2 weeks later

Interventions

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

healthy controlspatients with unilateral or bilateral, primary or secundary lower limb lymphedema (LLL)subgroup (n=40)

Assessor B: measurement methods and questionnaires for the assessment of LLLDIAGNOSTIC_TEST

healthy controlspatients 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 LLLDIAGNOSTIC_TEST

healthy controlspatients 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 LLLDIAGNOSTIC_TEST

subgroup (n=40)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

Pregnant participants
Presence of chronic venous insufficiency C4, C5, C6; deep venous thrombosis; post-thrombotic syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Universitaire Ziekenhuizen KU Leuvenlead
KU Leuvencollaborator

Study Sites (1)

University Hospitals of Leuven, center for lymphedema

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic Diseases

Study Officials

Tessa De Vrieze, Dr.
KU Leuven
PRINCIPAL INVESTIGATOR

Central Study Contacts

Tessa De Vrieze, Dr.

CONTACT

003216345006 tessa.devrieze@kuleuven.be

Study Design

Study Type: observational
Observational Model: CASE CONTROL
Time Perspective: OTHER
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 8, 2022

First Posted

March 7, 2022

Study Start

February 7, 2022

Primary Completion

September 1, 2025

Study Completion

October 1, 2025

Last Updated

July 3, 2024

Record last verified: 2024-07

Locations

BE(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (23)

Study Arms (3)

patients with unilateral or bilateral, primary or secundary lower limb lymphedema (LLL)

healthy controls

subgroup (n=40)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Locations