NCT05269264 Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Aim 1
| NCT ID | NCT05269264 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Lower Limb Lymphedema |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2022-02-07 |
| Primary Completion | 2025-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2022-02-07 with a primary completion date of 2025-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, 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.
Eligibility 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
Contact & Investigator
Tessa De Vrieze, Dr.
PRINCIPAL INVESTIGATOR
KU Leuven
Frequently Asked Questions
Who can join the NCT05269264 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lower Limb Lymphedema. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05269264 currently recruiting?
Yes, NCT05269264 is actively recruiting participants. Contact the research team at tessa.devrieze@kuleuven.be for enrollment information.
Where is the NCT05269264 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT05269264 clinical trial?
NCT05269264 is sponsored by Universitaire Ziekenhuizen KU Leuven. The principal investigator is Tessa De Vrieze, Dr. at KU Leuven. The trial plans to enroll 200 participants.