The Effect of Inelastic Compression System on Quality of Life in People With Chronic Venous Insufficiency

NCT05051540 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-04-09

Study results available
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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.

Conditions

  • Chronic Venous Insufficiency

Interventions

DEVICE

Sigvaris Compreflex Inelastic Compression Wrap

Compreflex compression system using wraps to apply compression of 30-40 mmHg.

Sponsors & Collaborators

  • University of Miami

    lead OTHER

Principal Investigators

  • Hadar Lev-Tov, MD · University of Miami

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-15
Primary Completion
2023-05-17
Completion
2023-05-17
FDA Device
Yes

Countries

  • United States

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 NCT05051540 on ClinicalTrials.gov