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NCT05051540 Clinical Trial

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

Chronic Venous Insufficiency Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05051540
Other study ID # 20210807
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 15, 2021
Est. completion date September 1, 2024

Study information
Verified date May 2024
Source University of Miami
Contact Maria Muniz
Phone 305-689-2646
Email mmuniz@med.miami.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date September 1, 2024
Est. primary completion date March 22, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Sigvaris Compreflex Inelastic Compression Wrap
Compreflex compression system using wraps to apply compression of 30-40 mmHg.

Locations
Country Name City State
United States University of Miami Miami Florida

Sponsors (1)
Lead Sponsor Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in the Quality of Life as measured by CIVIQ-20 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. Baseline to 6 weeks
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