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Study identifier: NCT06038864 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Aim 4

Condition: Lower Limb Lymphedema  ·  Sponsor: KU Leuven

PhaseN/A
Planned participants120
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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 charac…

This description comes directly from the study's public registry record.

Talk to the study team

Tessa De Vrieze, Dr.  ·  003216345006  ·  tessa.devrieze@kuleuven.be

Nele Devoogdt, Prof. Dr.  ·  0032 16 342515  ·  nele.devoogdt@kuleuven.be

Always discuss trial participation with your own doctor first.

Locations (2)

University Hospitals of LeuvenLeuven, BelgiumRecruiting
Nij Smellinghe HospitalDrachten, NetherlandsNot Yet Recruiting

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Source record: clinicaltrials.gov/study/NCT06038864