Actively Recruiting
Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Aim 1
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-03
200
Participants Needed
1
Research Sites
190 weeks
Total Duration
On this page
Sponsors
U
Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
K
KU Leuven
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Aim 1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Age, gender & BMI-matched healthy controls
You will not qualify if you...
- Pregnant participants
- Presence of chronic venous insufficiency C4, C5, C6; deep venous thrombosis; post-thrombotic syndrome
- Presence of skin infections or wounds at the level of the lower limbs at the moment of inclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Hospitals of Leuven, center for lymphedema
Leuven, Belgium, 3000
Actively Recruiting
Research Team
T
Tessa De Vrieze, Dr.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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