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

NCT07236307 | Completed

• 1 other identifier: 244/CEFMUP/2024
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Quality of life in CVD patients (CIVIQ-14 questionnaire)

  CIVIQ (Chronic Venous Insufficiency Quality of Life Questionnaire); The score for each dimension was obtained by adding up the scores of each constituent item and the global index was obtained by adding up the scores of the items. Items were weighted equally. The minimum and maximum values of the scales are dependent on the number of items used in each of the dimensions and on the number of levels or categories for each item. In order to compare the mean scores between dimensions or scales, absolute scores were then converted into an index. For each dimension, we therefore obtained a result ranging from 0 to 100. In order to facilitate interpretation of the results, the scoring system can be reversed. According to this scoring method, improvement in quality of life between two study times is represented by an increase in score.

  One week of overnight UZit® use (baseline and after 1 week)

Secondary Outcomes (2)

• Ankle circumference in CVD patients

  One week without intervention (measurements taken twice daily) and one week with UZit® use (measurements taken twice daily)

• Adverse events and participant satisfaction during UZit® use

  One week of overnight UZit® use

Study Arms (1)

UZit® Intervention

EXPERIMENTAL

Device: UZit®

Interventions

UZit® DEVICE

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.

UZit® Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients recruited from the outpatient setting of Casa de Saúde da Boavista, where they were evaluated due to worsening of their CVD symptoms

You may not qualify if:

• Peripheral artery disease
• Congestive heart failure
• Gastroesophageal reflux
• Inability to provide informed consent.

Sponsors & Collaborators

• Universidade do Porto: lead

Study Sites (1)

Casa da Saúde da Boavista

Porto, Portugal

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 19, 2025
• Study Start: April 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-10

Locations

PT (1)