Venous Insufficiency of LegNCT07236307
The Feasibility, Efficacy and Safety of UZit®: Single-arm Clinical Trial in Patients With Symptomatic Chronic Venous Disease
A study testing UZit® in people with Venous Insufficiency of Leg and Drainage, run by Universidade do Porto at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Venous Insufficiency of Leg, Drainage, Chronic Venous Disease
- What is being tested?
- UZit®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Apr 2025to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients recruited from the outpatient setting of Casa de Saúde da Boavista, where they were evaluated due to worsening of their CVD symptoms
Who cannot join
- Peripheral artery disease
- Congestive heart failure
- Gastroesophageal reflux
- Inability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
This single-arm clinical trial evaluates 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.
- Being tested
- UZit®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| UZit® Intervention | Experimental | Not described Receives: Device: UZit® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One week of overnight UZit® use (baseline and after 1 week)
Secondary outcomes (2)
Ankle circumference in CVD patients
Measured: 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
Measured: One week of overnight UZit® use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start1 Apr 2025
- Primary completion1 Aug 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Insufficiency of LegStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236307
- Sponsor's protocol ID
- 244/CEFMUP/2024
- Status last verified
- Oct 2025
- First submitted
- 14 Nov 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility, Efficacy and Safety of UZit®: Single-arm Clinical Trial in Patients With Symptomatic Chronic Venous Disease
- ClinicalTrials.gov ID
- NCT07236307
- Acronym / sponsor ID
- 244/CEFMUP/2024
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This single-arm clinical trial evaluates 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UZit® Intervention | Experimental | Device: UZit® |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients recruited from the outpatient setting of Casa de Saúde da Boavista, where they were evaluated due to worsening of their CVD symptoms
Key exclusion criteria (4 listed)
- Peripheral artery disease
- Congestive heart failure
- Gastroesophageal reflux
- Inability to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | UZit® Intervention |
Primary outcome
Quality of life in CVD patients (CIVIQ-14 questionnaire)
Time frame: One week of overnight UZit® use (baseline and after 1 week)
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.
2 secondary outcomes
Ankle circumference in CVD patients
Time frame: 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
Time frame: One week of overnight UZit® use
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UZit® in people with Venous Insufficiency of Leg and Drainage, run by Universidade do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life in CVD patients (CIVIQ-14 questionnaire) (time frame: One week of overnight UZit® use (baseline and after 1 week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.