N/A N=30 Treatment

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

Chronic Venous Insufficiency

Bottom Line

View on ClinicalTrials.gov: NCT05051540 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2025

Primary outcome: Primary: Change in the Quality of Life as Measured by CIVIQ-20 — 12.2 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Sigvaris Compreflex Inelastic Compression Wrap (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Miami
Primary completion: May 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in the Quality of Life as Measured by CIVIQ-20	12.2	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05051540). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.