EdemaWear to Reduce Edema in Hospitalized Patients With CVI:

Study Overview
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Brief Summary
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The purpose of this pilot study is to evaluate the effectiveness of EdemaWear® fuzzy wale longitudinal compression stockings on reducing lower extremity edema in hospitalized adult patients with a history of CVI who are at high risk of consequent venous leg ulcers (VLU) and patient experience with continuously wearing Edema Wear for up to five days

Detailed Description
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Hospitalized patients with chronic venous insufficiency (CVI) are at high risk of venous leg ulcers (VLU) due to lower leg edema and skin changes. Since VLU are associated with prolonged morbidity and appreciable financial burden to the patient and society, prevention of VLU by reduction of lower leg edema is paramount. Although the mainstay of VLU prevention is compression, there is a gap in the acute care toolbox to manage the symptom of CVI edema. Currently, ACE bandages are the single most common 'compression wraps' stocked on inpatient units. The disadvantages of ace wraps, which are long-stretch bandages, are two-fold: 1) lower working pressure impeding venous return to the heart, and 2) higher resting pressure that may cause a tourniquet effect and consequent tissue ischemia. A newer moderately-priced mild compression product (15-20 mmHg), EdemaWear® longitudinal elastic compression stockinet, offers an alternative for hospitalized patients. There is limited evidence about the effectiveness of EdemaWear® (that is, modest reduction of lower leg edema) derived from one case series and two comparative evaluations involving only patients in out-patient clinics. This pilot study will expand the evidence related to the effectiveness of EdemaWear® in reducing lower leg edema to include hospitalized patients with CVI. . The proposed pilot interventional study which involves a single-group repeated measures design with mixed methods has three aims: evaluate the effectiveness of EdemaWear fuzzy wale elastic compression stockinet in reducing lower extremity edema in hospitalized adult patients with chronic venous insufficiency as measured by the difference in the volume of each lower extremity from Day 1 and Day 5 of data collection or the day of discharge if it occurs in less than five days determine through interviews the experience of patients continuously wearing EdemaWear compression garment for up to five days or hospital discharge if it occurs in less than five days qualitatively describe nurses' perceptions of their patients experience with continuously wearing EdemaWear compression garment for up to five days or hospital discharge if it occurs in less than five days The procedure: Initial data collection related to demographic variables (age, gender, race, ethnic background), primary diagnosis, comorbid conditions (Charlson Comorbidity Index), CEAP classification of chronic venous disease, medication / treatment regimen, degree of lower extremity edema, volume of lower leg peripheral pulses, ankle-brachial indexes Daily data collection related to changes in health status and treatment Daily measurement of the girth of both lower extremities at 10 cm intervals from mid-foot, up the legs, to just below the knees. Daily interviews of patient and nursing staff related to experience of continuously wearing EdemaWear for up to five days or hospital discharge if it occurs in less than five days Data analysis: - Descriptive statistics will be performed on demographic and physiological variables, including number / percent for nominal variables and mean (+SD) for continuous variables. Data will be analyzed to decide whether they meet the assumptions of the planned analyses. Repeated measures ANOVA will be used to determine whether there are significant differences in the volume of the lower legs treated with EdemaWear® across the five time periods. The alpha level will be set at p < .05. Qualitative data from daily interviews of patients and nursing staff will be analyzed by the PI and Co-Is of this study. Content analysis will be used to analyze the data. The unit of analysis will be phrases or sentences contained in responses to questions in the Interview Guides. Content Analysis is a qualitative research method that is used to isolate and interpret themes, issues, and repeated patterns. They refine understanding as new insights about the data emerge. The strategies for analysis outlined by Downe - Wamboldt will be followed.

Official Title
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EdemaWear to Reduce Edema in Hospitalized Patients With Chronic Venous Insufficiency: A Pilot Study

Conditions
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Chronic Venous Insufficiency

Intervention / Treatment
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* Device: Edema Wear fuzzy wale compression garment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: history of CVI (Clinical classification 1-5), with > 2+ edema of the lower legs, > 2+ peripheral pulses (popliteal, dorsalis pedis [DP], and posterior tibial [PT]) or audible biphasic / triphasic Doppler signal, if pulses not palpable. Exclusion Criteria: open venous stasis ulcer(s) or other wounds on lower legs lymphedema or risk factors for lymphedema acute heart failure with active management known deep vein thrombosis (DVT) with subtherapeutic anticoagulation peripheral arterial disease (PAD) with reduced / absent pulses known or suspected inferior vena caval (IVC) compression circumference of lower leg < 45 cm or > 115 cm (size limits of small and extra-large EdemaWear®) severely altered mental status or lacking capacity to consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Edema Wear<br>Edema Wear fuzzy wale compression garment worn on lower extremities continuously for 5 days or until discharge if less than 5 days. | Device: Edema Wear fuzzy wale compression garment<br>* net-like compression structure of Lycra spandex elastic yarn with longitudinal fuzzy wales (similar to corduroy fabric)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in lower leg volume | Difference between volume of lower leg / foot between Day 1 and Day 5 (or day of hospital discharge if less than 5 days) | up to 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Venous Insufficiency, CVI