Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Aim 3 (EvaLymph-Leg3)

Catholic University (KU) of Leuven

Status: Enrolling

Conditions: Lower Limb Lymphedema

Treatments: Diagnostic Test: Lower Limb Lymhedema assessment

Study type: Observational

Funder types: Other

Identifiers

NCT05757284

s66033-aim3

Details and patient eligibility

About

The current best practice is a three-stage classification consensus guideline as published by the International Society of Lymphology (ISL). Severity of lymphedema is however not only determined by presence of pitting (which is the phenomenon when the swollen area has a dimple (or pit) after you press it for 5 to 10 seconds) and presence of adipose tissue or not, but is also determined by the volume of the edema, a quantification of the condition of the skin and the location/expansion of the edema over the body. Currently a severity score considering these different aspects does not exist. Although there is consensus that the ISL staging systems is a necessary part of the diagnosis of lymphedema, it gives not enough information about the severity of the lymphedema. A more detailed and comprehensive classification system applicable for primary and secondary lymphedema and considering multiple edema characteristics, remains to be formulated.

The researchers objective in this study is to develop a diagnostic set, including a 'severity score', for patients with LLL.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patient group

• Unilateral or bilateral, primary or secondary 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

140 participants in 2 patient groups

patients with unilateral or bilateral, primary or secundary LLL

Treatment:

Diagnostic Test: Lower Limb Lymhedema assessment

healthy controls

Treatment:

Diagnostic Test: Lower Limb Lymhedema assessment