Creating a tool to assess lower limb lymphedema
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
This study is testing different ways to measure lower limb lymphedema to see which methods work best for doctors and patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven) |
| Trial ID | NCT05269264 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the reliability and clinical feasibility of various measurement methods used to assess lower limb lymphedema (LLL). It will involve multiple assessors conducting measurements and questionnaires to gather data on the same patients over time. The study seeks to clarify the effectiveness of different assessment tools, such as water displacement and perimetry, in diagnosing and monitoring LLL. By comparing these methods, the study hopes to provide a clearer understanding of which tools are most reliable for clinical use.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with unilateral or bilateral lower limb lymphedema, confirmed by specific diagnostic criteria.
Not a fit: Patients with chronic venous insufficiency, deep venous thrombosis, or skin infections in the lower limbs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved assessment methods for lower limb lymphedema, enhancing patient care and treatment outcomes.
How similar studies have performed: While there is ongoing research in lymphedema assessment, this study's specific focus on comparing measurement tools is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Criteria: * 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
Where this trial is running
Leuven
- University Hospitals of Leuven, center for lymphedema — Leuven, Belgium (Recruiting)
Study contacts
- Principal investigator: Tessa De Vrieze, Dr. — KU Leuven
- Study coordinator: Tessa De Vrieze, Dr.
- Email: tessa.devrieze@kuleuven.be
- Phone: 003216345006
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.