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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

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

Qualifiers

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

Disqualifiers

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

Treatments tested in this trial

  • Assessor A (first measurement): measurement methods and questionnaires for the assessment of LLL
  • Assessor B: measurement methods and questionnaires for the assessment of LLL
  • Assessor A (second measurement: measurement methods and questionnaires for the assessment of LLL
  • Assessor A (2 weeks later): measurement methods and questionnaires for the assessment of LLL

Treatment groups

200 Participants
are divided into 3 treatment groups

Sponsors and collaborators