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

Not Applicable

Completed

• Conditions: Venous Insufficiency of Leg; Chronic Venous Disease; Drainage

• Registration Number: NCT07236307
• Lead Sponsor: Universidade do Porto

Brief Summary

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.

In addition to leg elevation, patients were advised to follow all other recommendations from their vascular surgeon (e.g., use of compression stockings, venotonic medications, etc.).

The primary outcome was quality of life in CVD patients, assessed with the Portuguese translation of the CIVIQ-14 questionnaire, a validated and sensitive tool for detecting CVD-related changes. Patients completed the questionnaire at baseline and after one week of overnight UZit® use.

Secondary outcomes included ankle circumference and adverse events. Ankle circumference was measured twice daily-immediately after waking and before bedtime-just above the malleolus, using a "Smart Tape Measure Body" digital device (resolution 0.1 cm, accuracy ±2%). Measurement points were marked on the skin with an "Edding 3000" marker, which patients refreshed daily.

Participants were specifically asked about low back pain during limb elevation and any other symptoms during the intervention and the level of satisfaction using a scale from 0 to 5.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-04-01
• Primary Completion: 2025-08-01
• Study Completion: 2025-09-01
• Status Verified: 2025-10
• Study First Submitted: 2025-11-14
• Study First Submitted QC: 2025-11-14
• Last Update Submitted: 2025-11-14
• Study First Posted: 2025-11-19
• Last Update Posted: 2025-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• Patients recruited from the outpatient setting of Casa de Saúde da Boavista, where they were evaluated due to worsening of their CVD symptoms, were invited to participate. Inform consent was obtained.

Exclusion Criteria

• Peripheral artery disease, congestive heart failure, gastroesophageal reflux, and inability to provide informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Quality of life in CVD patients (CIVIQ-14 questionnaire)	One week of overnight UZit® use (baseline and after 1 week)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Casa da Saúde da Boavista; 🇵🇹 Porto, Portugal