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

NCT05051540 | Completed Results FDA Device

• 1 other identifier: 20210807
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Device: Sigvaris Compreflex Inelastic Compression Wrap

Interventions

Sigvaris Compreflex Inelastic Compression Wrap DEVICE

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

Inelastic Compression System Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Results Point of Contact

• Title: Hadar Lev-Tov, MD
• Organization: University of Miami

hlevtov@med.miami.edu

305-243-1953

Study Officials

• Hadar Lev-Tov, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: September 21, 2021
• Study Start: November 15, 2021
• Primary Completion: May 17, 2023
• Study Completion: May 17, 2023
• Last Updated: April 9, 2025
• Results First Posted: April 9, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)