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

University of Miami30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Venous Insufficiency

Interventions

Sigvaris Compreflex Inelastic Compression WrapDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Miami

Miami, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline to 6 weeks

Data from ClinicalTrials.gov

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