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The Feasibility, Efficacy and Safety of UZit®: Single-arm Clinical Trial in Patients With Symptomatic Chronic Venous Disease

Universidade do Porto · 2025
ClinicalTrials.gov · Datasets · License: Public Domain · 2025
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drainagena
The goal of this single-arm clinical trial is to learn whether overnight limb elevation using the UZit® device can improve symptoms and signs of chronic venous disease (CVD) in adults. The main questions it aims to answer are: Does one week of overnight UZit® use improve quality of life in patients with CVD? Does UZit® use reduce ankle circumference and are there any adverse events associated with its use? Because there is no comparison group, all participants will use the UZit® device to determine whether these effects occur. Participants will: Use the UZit® device every night for one consecutive week. Follow their vascular surgeon's existing recommendations (e.g., compression stockings, venotonic medications). Complete the CIVIQ-14 questionnaire at baseline and after one week of using the device to assess quality of life. Measure ankle circumference twice daily (upon waking and before bedtime) using a digital tape measure, following marked anatomical points. Report any symptoms-including low back pain-and rate their satisfaction with the device on a 0-5 scale.
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