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

Not Applicable

Completed

• Conditions: Chronic Venous Insufficiency
• Interventions: Device: Sigvaris Compreflex Inelastic Compression Wrap

• Registration Number: NCT05051540
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-10
• Study First Submitted QC: 2021-09-10
• Study First Posted: 2021-09-21
• Study Start: 2021-11-15
• Primary Completion: 2023-05-17
• Study Completion: 2023-05-17
• Status Verified: 2025-03
• Results First Submitted: 2025-03-25
• Results First Submitted QC: 2025-03-25
• Last Update Submitted: 2025-03-25
• Results First Posted: 2025-04-09
• Last Update Posted: 2025-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Inelastic Compression System Group	Sigvaris Compreflex Inelastic Compression Wrap	Participants in this group will receive the inelastic compression wrap for daily use on their legs for 6 consecutive weeks.

Primary Outcome Measures

Name	Time	Method
Change in the Quality of Life as Measured by CIVIQ-20	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.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States