Chronic Venous InsufficiencyNCT05051540
The Effect of Inelastic Compression System on Quality of Life in People With Chronic Venous Insufficiency
A study testing Sigvaris Compreflex Inelastic Compression Wrap in people with Chronic Venous Insufficiency, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this protocol is to measure the effect of the use of an inelastic compression system (ICS) on quality of life (QOL) in patients with chronic venous insufficiency (CVI) who have demonstrated limited or no compliance with prescribed compression stockings or bandage wraps. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Venous Insufficiency
- What is being tested?
- Sigvaris Compreflex Inelastic Compression Wrap
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2021to 17 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is age 18 or older, able and willing to provide consent and agrees to comply with the study procedures
- Subject must have chronic venous insufficiency of stages C3, C4, or C5 according to the Clinical-Etiological-Anatomical-Pathophysiological (CEAP) classification system
- Not compliant with their currently prescribed compression system
Who cannot join
- Active malignancy other than non-melanoma skin cancer
- Study ulcer suspicious for cancer
- Subjects who are pregnant and/or breastfeeding
- In the opinion of the PI the subject cannot comply with study procedures
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this protocol is to measure the effect of the use of an inelastic compression system (ICS) on quality of life (QOL) in patients with chronic venous insufficiency (CVI) who have demonstrated limited or no compliance with prescribed compression stockings or bandage wraps.
- Conditions
- Chronic Venous Insufficiency
- Being tested
- Sigvaris Compreflex Inelastic Compression Wrap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sigvaris Compreflex Inelastic Compression WrapDevice
Compreflex compression system using wraps to apply compression of 30-40 mmHg.
| Study group | Role | What they receive |
|---|---|---|
| Inelastic Compression System Group | Experimental | Participants in this group will receive the inelastic compression wrap for daily use on their legs for 6 consecutive weeks. Receives: Device: Sigvaris Compreflex Inelastic Compression Wrap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Quality of Life as Measured by CIVIQ-20
Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20) consists of 20 multiple choice questions subdivided into four categories: psychology, pain, physical repercussions and social repercussions. The questionnaire has a total score ranging from 0 to 100 the lower score indicating greater quality of life.
Measured: Baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start15 Nov 2021
- Primary completion17 May 2023
- Study completion17 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Venous InsufficiencyStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadar Lev-Tov, University of Miami
- Investigators
- Hadar Lev-Tov, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05051540
- Sponsor's protocol ID
- 20210807
- Status last verified
- Mar 2025
- First submitted
- 10 Sep 2021
- Last updated
- 9 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Inelastic Compression System on Quality of Life in People With Chronic Venous Insufficiency
- ClinicalTrials.gov ID
- NCT05051540
- Acronym / sponsor ID
- 20210807
- Conditions
- Chronic Venous Insufficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 17 May 2023 (actual)
- Study completion
- 17 May 2023 (actual)
- First posted
- 21 Sep 2021 (actual)
- Results
- Posted 9 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this protocol is to measure the effect of the use of an inelastic compression system (ICS) on quality of life (QOL) in patients with chronic venous insufficiency (CVI) who have demonstrated limited or no compliance with prescribed compression stockings or bandage wraps.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inelastic Compression System Group | Experimental | Device: Sigvaris Compreflex Inelastic Compression WrapParticipants in this group will receive the inelastic compression wrap for daily use on their legs for 6 consecutive weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject is age 18 or older, able and willing to provide consent and agrees to comply with the study procedures
- Subject must have chronic venous insufficiency of stages C3, C4, or C5 according to the Clinical-Etiological-Anatomical-Pathophysiological (CEAP) classification system
- Not compliant with their currently prescribed compression system
Key exclusion criteria (4 listed)
- Active malignancy other than non-melanoma skin cancer
- Study ulcer suspicious for cancer
- Subjects who are pregnant and/or breastfeeding
- In the opinion of the PI the subject cannot comply with study procedures
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 |
|---|---|---|
| Sigvaris Compreflex Inelastic Compression WrapCompreflex compression system using wraps to apply compression of 30-40 mmHg. | Device | Inelastic Compression System Group |
Primary outcome
Change in the Quality of Life as Measured by CIVIQ-20
Time frame: Baseline to 6 weeks
Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20) consists of 20 multiple choice questions subdivided into four categories: psychology, pain, physical repercussions and social repercussions. The questionnaire has a total score ranging from 0 to 100 the lower score indicating greater quality of life.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Hadar Lev-Tov, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sigvaris Compreflex Inelastic Compression Wrap in people with Chronic Venous Insufficiency, run by University of Miami at 1 site in United States.
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 3 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 9 Apr 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 United States. 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?
Yes. Results are posted in the registry (first posted 9 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in the Quality of Life as Measured by CIVIQ-20 (time frame: Baseline to 6 weeks). 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 9 Apr 2025.