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

NCT07236307 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2025-12-10

No results posted yet for this study

Summary

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.

Conditions

  • Venous Insufficiency of Leg
  • Drainage
  • Chronic Venous Disease

Interventions

DEVICE

UZit®

This is single-arm clinical trial to evaluate the effect of limb elevation with UZit®. Participants were invited to use UZit® overnight for one consecutive week to improve symptoms and signs of CVD of the lower limbs. UZit® (PPP-118717; technical Data Sheet in Supplementary Data 1) is an inflatable wedge-shaped device made of thermoplastic polyurethane (Figure 1), placed under a traditional mattress. When inflated, it creates an inclined plane of approximately 5%, optimizing venous circulation during rest. By evenly inclining the entire body, it avoids lumbar spine movement regardless of sleeping position.

Sponsors & Collaborators

  • Universidade do Porto

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2025-08-01
Completion
2025-09-01

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07236307 on ClinicalTrials.gov