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
Sponsors and collaborators
Universitaire Ziekenhuizen KU Leuven
Lead sponsor
KU Leuven
Collaborator