The Effect of Inelastic Compression System on Quality of Life in People With Chronic Venous Insufficiency
NCT05051540 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2025-04-09
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
Interventions
- DEVICE
-
Sigvaris Compreflex Inelastic Compression Wrap
Compreflex compression system using wraps to apply compression of 30-40 mmHg.
Sponsors & Collaborators
-
University of Miami
lead OTHER
Principal Investigators
-
Hadar Lev-Tov, MD · University of Miami
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-11-15
- Primary Completion
- 2023-05-17
- Completion
- 2023-05-17
- FDA Device
- Yes
Countries
- United States
Study Locations
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