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

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

Recruiting
18 years and older
All
Phase N/A

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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.

Eligibility

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

Study details
    Lower Limb Lymphedema

NCT05269264

Universitaire Ziekenhuizen KU Leuven

14 October 2025

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