Chronic Venous Insufficiency
Conditions
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.
Interventions
DEVICESigvaris Compreflex Inelastic Compression Wrap
Compreflex compression system using wraps to apply compression of 30-40 mmHg.
Sponsors
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Quality of Life as Measured by CIVIQ-20 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Inelastic Compression System Group | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 13 Participants | — |
| Age, Categorical Between 18 and 65 years | 17 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 17 Participants | — |
| Sex: Female, Male Male | 13 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
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.
Time frame: Baseline to 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inelastic Compression System Group | Change in the Quality of Life as Measured by CIVIQ-20 | 12.2 score on a scale | Standard Deviation 21.06 |