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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Venous Insufficiency
• Intervention / Treatment: Device: Sigvaris Compreflex Inelastic Compression Wrap

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria Muniz; Phone Number: 305-689-2646; Email: mmuniz@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Contact: Maria Muniz; Phone Number: 305-689-2646; Email: mmuniz@med.miami.edu
      • Principal Investigator: Hadar Lev-Tov, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Inelastic Compression System Group; Participants in this group will receive the inelastic compression wrap for daily use on their legs for 6 consecutive weeks.	Device: Sigvaris Compreflex Inelastic Compression Wrap; Compreflex compression system using wraps to apply compression of 30-40 mmHg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 6 weeks

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Hadar Lev-Tov, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2021
• Primary Completion (Actual): March 22, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: September 10, 2021
• First Submitted That Met QC Criteria: September 10, 2021
• First Posted (Actual): September 21, 2021

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Venous Insufficiency
• Other Study ID Numbers: 20210807

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No