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

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.

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Key information

Conditions

Chronic Venous Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Sigvaris Compreflex Inelastic Compression Wrap

Device

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

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Sep 21, 2021
Registry last updated: Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed