NCT05051540

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

Completed NA Results posted Last updated 9 April 2025

What this trial tests

NA trial testing Sigvaris Compreflex Inelastic Compression Wrap in Chronic Venous Insufficiency in 30 participants. Completed in 17 May 2023.

Timeline

15 November 2021

Primary endpoint
17 May 2023

17 May 2023

Quick facts

Lead sponsor	University of Miami
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	15 November 2021
Primary completion	17 May 2023
Estimated completion	17 May 2023
Sites	1 location across United States

Drugs / interventions tested

• Sigvaris Compreflex Inelastic Compression Wrap

Conditions studied

• Chronic Venous Insufficiency — all drugs for Chronic Venous Insufficiency →

Sponsor

University of Miami

Who can join

18 and older, any sex, with Chronic Venous Insufficiency. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in the Quality of Life as Measured by CIVIQ-20 Primary · 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.

Group	Value	95% CI
Inelastic Compression System Group	12.2	± 21.06

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Effect of Inelastic Compression Wraps on the Quality of Life of People with Chronic Venous Insufficiency: A Single-Center, Single-Arm, Prospective Study.
   Smits AH, Yaghi M, Maskan Bermudez N, Lev-Tov H. · · 2025 · cited 1× · PMID 40217725 · DOI 10.3390/jcm14072275