NCT06038864 Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Aim 4
| NCT ID | NCT06038864 |
| Status | Recruiting |
| Phase | — |
| Sponsor | KU Leuven |
| Condition | Lower Limb Lymphedema |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2025-03-01 |
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 120 participants in total. It began in 2024-04-01 with a primary completion date of 2025-03-01.
⚠ 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
Research investigating measurement properties for evaluating the decongestive treatment effect on different edema characteristics (e.g. water volume, hardness of the skin, water content,..) at the level of the lower limbs is missing. Information about the clinical relevant change criteria after treatment for nearly all these edema characteristics, is not present and requires investigation. To assess the merits of each treatment in a reproducible manner, a reliable way of measuring limb volume and other edema characteristics must be established, as the evaluation of treatment effects without appropriate tools might lead to biased treatment effects. First of all, in clinical practice, it is of utmost importance to know which edema characteristics need to be evaluated in order to assess the clinical evolution of a patient with lymphedema during and after treatment. Secondly, in order to draw proper conclusions about the treatment effect, it is necessary that to know from which criterion (or cut-off value) one can speak of a real clinical change for a certain lymphedema characteristic. Given that the edema characteristics that are most responsive to treatment and their corresponding criteria for clinically significant and relevant changes at the lower limbs have never been investigated before, the need for this research is high. Therefore, the research questions in this study are: Which measurement tool(s) are able to detect clinically relevant changes in the lymphedema characteristics after the intensive treatment and during the maintenance treatment? When can a clinician speak of a clinically relevant change?
Eligibility Criteria
Inclusion Criteria: * Intensive treatment group * Unilateral or bilateral, primary or secondary LLL * No active metastases * If cancer-related lymphedema, time interval since surgery/ radiotherapy/ chemotherapy is ≥3 months * Objective diagnosis of lymphedema: ≥ 5% volume difference OR ≥ 2 minor/ 1 major criteria on lymphoscintigraphy OR presence of ICG dermal backflow * Age ≥ 18 years * Able to read, understand and speak Dutch * Planned to start with intensive decongestive lymphatic therapy at one or both legs * Maintenance treatment group * See inclusion criteria 'intensive treatment group' * But: instead of patients planned to start with intensive lymphatic therapy, patients of this group should have ended their intensive treatment phase at least 3 months ago (= currently receiving maintenance decongestive lymphatic therapy) 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 NCT06038864 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 NCT06038864 currently recruiting?
Yes, NCT06038864 is actively recruiting participants. Contact the research team at tessa.devrieze@kuleuven.be for enrollment information.
Where is the NCT06038864 trial being conducted?
This trial is being conducted at Leuven, Belgium, Drachten, Netherlands.
Who is sponsoring the NCT06038864 clinical trial?
NCT06038864 is sponsored by KU Leuven. The principal investigator is Tessa De Vrieze, Dr. at KU Leuven. The trial plans to enroll 120 participants.