Creating a new tool to assess lower limb lymphedema severity
Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Development of a Diagnostic Set for Patients With LLL
This study is trying to create a new tool to better measure how severe lower limb lymphedema is in patients so that they can receive better care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | KU Leuven Academic / other |
| Locations | 2 sites (Leuven and 1 other locations) |
| Trial ID | NCT05757284 on ClinicalTrials.gov |
What this trial studies
This study aims to develop a comprehensive clinical screening and diagnostic tool for patients with lower limb lymphedema. Current classification systems do not adequately capture the severity of the condition, which is influenced by various factors such as edema volume and skin condition. By formulating a new severity score that incorporates these aspects, the researchers hope to improve the diagnosis and management of lymphedema. The study will include both patients with lymphedema and healthy controls for comparison.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of unilateral or bilateral lower limb lymphedema.
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 tool could lead to more accurate diagnoses and better treatment plans for patients with lower limb lymphedema.
How similar studies have performed: While there is existing research on lymphedema classification, this specific approach to developing a comprehensive severity score is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patient group * Unilateral or bilateral, primary or secondary 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 and 1 other locations
- University Hospitals of Leuven — Leuven, Belgium (Recruiting)
- Nij Smellinghe Hospital — Drachten, Netherlands (Not_yet_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.