Trial Outcomes & Findings for The Effect of Inelastic Compression System on Quality of Life in People With Chronic Venous Insufficiency (NCT NCT05051540)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

Baseline to 6 weeks

Results posted on

2025-04-09

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Inelastic Compression System Group n=30 Participants 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.
Age, Categorical <=18 years	0 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=30 Participants
Age, Categorical >=65 years	13 Participants n=30 Participants
Sex: Female, Male Female	17 Participants n=30 Participants
Sex: Female, Male Male	13 Participants n=30 Participants

PRIMARY outcome

Timeframe: Baseline to 6 weeks

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.

Outcome measures

Outcome measures
Measure	Inelastic Compression System Group n=30 Participants 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.
Change in the Quality of Life as Measured by CIVIQ-20	12.2 score on a scale Standard Deviation 21.06

Adverse Events

Inelastic Compression System Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Hadar Lev-Tov, MD

University of Miami

Phone: 305-243-1953

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place