Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Aim 1 (EvaLymph-Leg1)

Universitaire Ziekenhuizen KU Leuven

Status: Enrolling

Conditions: Lower Limb Lymphedema

Treatments: Diagnostic Test: Assessor B: 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; Diagnostic Test: Assessor A (second measurement: measurement methods and questionnaires for the assessment of LLL; Diagnostic Test: Assessor A (first measurement): measurement methods and questionnaires for the assessment of LLL

Study type: Observational

Funder types: Other

Identifiers

NCT05269264

s66033-aim1

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

200 participants in 3 patient groups

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

Description:

patients with unilateral or bilateral, primary or secundary LLL who visit the center for lymphedema at UH Leuven

Treatment:

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

healthy controls

Description:

age, BMI and gender matched to the patients with LLL

Treatment:

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

subgroup (n=40)

Description:

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

Treatment:

Diagnostic Test: Assessor A (first 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

Diagnostic Test: Assessor A (second measurement: measurement methods and questionnaires for the assessment of LLL

Diagnostic Test: Assessor B: measurement methods and questionnaires for the assessment of LLL