Clinical trial NCT05269264: Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Aim 1
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lower Limb Lymphedema
Keywords: Lymphedema
Measurement
Clinical evaluation
Reliability
Concurrent validity
Clinical feasibility
Lower limb
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: KU Leuven
First posted: 2022-03-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_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.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Within-session reliability of pitting test at the level of the foot, leg and midline region
timeFrame: baseline (within-session)
measure: Within-session reliability of skinfold test at the level of the foot, leg and midline region
timeFrame: baseline (within-session)
measure: Within-session reliability of skin hardness test at the level of the foot, leg and midline region
timeFrame: baseline (within-session)
measure: Within-session reliability of measurement with MoistureMeterD at the level of the foot, leg and midline region
timeFrame: baseline (within-session)
measure: Within-session reliability of measurement with SkinFibroMeter at the level of the foot, leg and midline region
timeFrame: baseline (within-session)
measure: Within-session reliability of circumference measurements at the level of the leg and midline region
timeFrame: baseline (within-session)
measure: Within-session reliability of perometry at the level of the leg
timeFrame: baseline (within-session)
measure: Within-session reliability of water displacement measurement at the level of the foot
timeFrame: baseline (within-session)
measure: Within-session reliability of measurements with bio-impedance spectroscopy/analysis devices at the level of the lower limbs
timeFrame: baseline (within-session)
measure: Within-session reliability of a questionnaire regarding skin integrity
timeFrame: baseline (within-session)
measure: Concurrent validity (only possible in case there are multiple measurement methods assessing the same lymphedema characteristic) of measurement methods for the assessment of LLL
timeFrame: baseline (within-session)
measure: Clinical feasibility of measurement methods and questionnaires for the assessment of Lower lymb lymphoedema
timeFrame: baseline (within-session)
measure: Between-session reliability of pitting test at the level of the foot, leg and midline region
timeFrame: 2 weeks
measure: Between-session reliability of skinfold test at the level of the foot, leg and midline region
timeFrame: 2 weeks
measure: Between-session reliability of skin hardness test at the level of the foot, leg and midline region
timeFrame: 2 weeks
measure: Between-session reliability of measurement with MoistureMeterD at the level of the foot, leg and midline region
timeFrame: 2 weeks
measure: Between-session reliability of measurement with SkinFibroMeter at the level of the foot, leg and midline region
timeFrame: 2 weeks
measure: Between-session reliability of circumference measurements at the level of the leg and midline region
timeFrame: 2 weeks
measure: Between-session reliability of perometry at the level of the leg
timeFrame: 2 weeks
measure: Between-session reliability of water displacement measurement at the level of the foot
timeFrame: 2 weeks
measure: Between-session reliability of measurements with bio-impedance spectroscopy/analysis devices at the level of the lower limbs
timeFrame: 2 weeks
measure: Between-session reliability of a questionnaire regarding skin integrity
timeFrame: 2 weeks
measure: Between-session reliability of a self-reported disease-specific quality of life questionnaire (Lymph-ICF-LL)
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals of Leuven, center for lymphedema
Study officials:
affiliation: KU Leuven
name: Tessa De Vrieze, Dr.
role: PRINCIPAL_INVESTIGATOR
References: