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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inelastic Compression System Group | Experimental | Participants in this group will receive the inelastic compression wrap for daily use on their legs for 6 consecutive weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sigvaris Compreflex Inelastic Compression Wrap | Device | Compreflex compression system using wraps to apply compression of 30-40 mmHg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hadar Lev-Tov, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 6 weeks |
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hadar Lev-Tov, MD | University of Miami | 305-243-1953 | hlevtov@med.miami.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 12, 2022 | Mar 24, 2025 | Prot_000.pdf |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Units | Counts |
|---|
| Participants |
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| 0 |
| 30 |
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| 30 |
| 0 |
| 30 |
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