The Effect of Inelastic Compression System on Quality of Life in People With Chronic Venous Insufficiency
NCT ID: NCT05051540
Last Updated: 2025-04-09
Study Results
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View full resultsBasic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2021-11-15
2023-05-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Inelastic Compression System Group
Participants in this group will receive the inelastic compression wrap for daily use on their legs for 6 consecutive weeks.
Sigvaris Compreflex Inelastic Compression Wrap
Compreflex compression system using wraps to apply compression of 30-40 mmHg.
Interventions
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Sigvaris Compreflex Inelastic Compression Wrap
Compreflex compression system using wraps to apply compression of 30-40 mmHg.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Miami
OTHER
Responsible Party
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Hadar Lev-Tov
Assistant Professor of Clinical
Principal Investigators
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Hadar Lev-Tov, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami
Miami, Florida, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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20210807
Identifier Type: -
Identifier Source: org_study_id
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