The Effect of Inelastic Compression System on Quality of Life in People With Chronic Venous Insufficiency
Status: Completed
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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
Locations
United States
Florida
University of Miami
Miami
Time Frame
Start Date: 2021-11-15
Completion Date: 2023-05-17
Participants
Target number of participants: 30
Treatments
Experimental: Inelastic Compression System Group
Participants in this group will receive the inelastic compression wrap for daily use on their legs for 6 consecutive weeks.
Authors
Hadar Lev-Tov
Related Therapeutic Areas
Sponsors
Leads: University of Miami