Back to resultsThe Effect of Inelastic Compression System on Quality of Life in People With Chronic Venous Insufficiency
Primary Purpose
Chronic Venous Insufficiency
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sigvaris Compreflex Inelastic Compression Wrap
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Venous Insufficiency
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
Sites / Locations
- University of MiamiRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Inelastic Compression System Group
Arm Description
Participants in this group will receive the inelastic compression wrap for daily use on their legs for 6 consecutive weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05051540
First Posted
September 10, 2021
Last Updated
August 23, 2023
Sponsor
University of Miami
1. Study Identification
Unique Protocol Identification Number
NCT05051540
Brief Title
The Effect of Inelastic Compression System on Quality of Life in People With Chronic Venous Insufficiency
Official Title
The Effect of Inelastic Compression System on Quality of Life in People With Chronic Venous Insufficiency
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Venous Insufficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Inelastic Compression System Group
Arm Type
Experimental
Arm Description
Participants in this group will receive the inelastic compression wrap for daily use on their legs for 6 consecutive weeks.
Intervention Type
Device
Intervention Name(s)
Sigvaris Compreflex Inelastic Compression Wrap
Intervention Description
Compreflex compression system using wraps to apply compression of 30-40 mmHg.
Primary Outcome Measure Information:
Title
Change in the Quality of Life as measured by CIVIQ-20
Description
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.
Time Frame
Baseline to 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Muniz
Phone
305-689-2646
Email
mmuniz@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hadar Lev-Tov, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Muniz
Phone
305-689-2646
Email
mmuniz@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Hadar Lev-Tov, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Inelastic Compression System on Quality of Life in People With Chronic Venous Insufficiency
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