Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Aim 1

Universitaire Ziekenhuizen KU Leuven200 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

200

Conditions

Lower Limb Lymphedema

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

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

Assessor A (second measurement: measurement methods and questionnaires for the assessment of LLLDIAGNOSTIC_TEST

Assessor A (2 weeks later): measurement methods and questionnaires for the assessment of LLLDIAGNOSTIC_TEST

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)