Status:
RECRUITING
Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Aim 1
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
KU Leuven
Conditions:
Lower Limb Lymphedema
Eligibility:
All Genders
18+ years
Brief Summary
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,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 7 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05269264
Start Date
February 7 2022
End Date
October 1 2025
Last Update
July 3 2024
Active Locations (1)
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1
University Hospitals of Leuven, center for lymphedema
Leuven, Belgium, 3000