Actively Recruiting
Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema (LLL): Reliability, Concurrent Validity and Clinical Feasibility of Currently Applied Measurement Tools in Patients With LLL
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-03
200
Participants Needed
1
Research Sites
4 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
Researchers are investigating the reliability, validity, and practical use of various measurement methods for assessing lower limb lymphedema (LLL). This observational cross-sectional study aims to provide clarity on how consistent and feasible these tools are for clinical practice, comparing assessments like water displacement, perimetry, skin hardness, and moisture content. The study particularly focuses on patients with LLL, evaluating day-to-day measurement consistency and clinical practicality. The study involves patients with unilateral or bilateral, primary or secondary LLL, as well as healthy controls matched by age, gender, and BMI. Measurement methods and questionnaires for LLL assessment are performed by different assessors, including tests for skinfold thickness, skin hardness, moisture, circumference, perometry, water displacement, bio-impedance, and skin integrity questionnaires. A subgroup of participants will be re-evaluated after two weeks to assess measurement reliability over time. Participants will undergo various measurement tests during initial visits, with some returning for a follow-up after two weeks. Assessments include physical tests at the foot, leg, and midline regions, and questionnaires on skin condition and quality of life related to LLL. The study measures within-session and between-session reliability, concurrent validity of methods assessing the same LLL characteristics, and clinical feasibility of these tools. This process helps researchers understand which methods provide reliable and practical results for managing LLL.
CONDITIONS
Brief 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% or more volume difference between legs OR 2 minor/1 major lymphoscintigraphy criteria OR presence of ICG dermal backflow
- Age 18 years or older
- Able to read, understand, and speak Dutch
- Healthy controls matched by age, gender, and BMI
You will not qualify if you...
- Pregnant participants
- Chronic venous insufficiency stages C4, C5, or C6
- Deep venous thrombosis
- Post-thrombotic syndrome
- Skin infections or wounds on the lower limbs at the time of inclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline session
Participants undergo multiple measurement methods and questionnaires to assess lower limb lymphedema, including physical tests and bio-impedance spectroscopy. These assessments are done by different assessors during the baseline evaluation.
2 visits (in-person) on the same day or closely scheduled for initial measurements
Duration - 2 weeks
A subgroup of participants is re-evaluated 2 weeks later using the same measurement methods and questionnaires to assess between-session reliability.
1 follow-up visit (in-person) approximately 2 weeks after baseline
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.
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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