Compression Aided Management of Edema in Patients With C3 Venous Disease

Study Overview
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Brief Summary
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Objectives: To quantify the clinical improvement and quality of life between patients wearing compression stockings versus anti-embolism stockings in patients with varicose veins and limb edema.

Detailed Description
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Research Design: Pilot study of patients presenting to vascular clinic with chronic venous disease with varicose veins and/or edema will be randomized 1:1 in one of two compression garment groups. Measurements of edema and the interface compression applied at the ankle will be determined. The venous clinical severity scoring system and quality of life are assessed. After 4 weeks of treatment patients will have repeat objective studies and clinical outcomes determined. Methodology: Patients with venous disease and edema and non-venous edema will be evaluated by clinical exam and venous duplex ultrasound. Patients eligible for the study will be randomized to knee-high 20-30 Hg graded compression stockings or anti-embolism (13-18 mm Hg) compression stockings. Patients will have limb quantitative edema assessment, a severity score and quality of life determination. Compression will be assigned to each treatment group with instruction on proper wear and duration, and the interface pressure of compression at the skin surface at the ankle level determined. Following 4 weeks of compression, patients will return for evaluation in the following areas: quantify limb edema, quantify compression at the ankle, venous clinical severity score, and venous disease specific quality of life. Data will be analyzed and presented as mean±sd. Data are analyzed using ANOVA followed by Scheffe's F test for comparison of multiple means. Student's t-test for unpaired and paired data will be used for comparison of two means. Differences are considered statistically significant if P < 0.05. Significance: Utilizing objective measures of leg edema and applied interface pressure with two different compression garments, the data will provide the important relation between compression (mm Hg) and function of an appropriate graded compression stocking in improving limb edema and symptoms. In addition, measuring clinical outcomes before and after compression will validate the usefulness of proper compression. This study is intended to identify important quantifiable parameters that may be useful in assessing treatment end point including: clinical improvement, length of treatment, daily treatment utilization, prognosis, and clinical guidelines for compression in a specific clinical setting.

Official Title
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Compression Versus Anti-Embolism Stockings in Patients With Leg Edema: Objective Investigation of Interface Compression and Edema Measurements, Clinical Outcomes, and Quality of Life.

Conditions
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Chronic Venous Disease

Intervention / Treatment
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* Device: Anti-embolism Knee High Stocking
* Device: 20-30 Knee High Compression Stocking


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with varicose veins exhibiting lower leg edema Unilateral or bi-lateral edema Exclusion Criteria: Generalized leg edema from renal disease, heart failure, liver disease or other undetermined cause Acute infection Hepatitis Steroid use immuno-deficiencies including HIV Acute deep venous thrombosis Have had leg surgery or other orthopedic procedure in past 6 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Anti-embolism Knee High compression stocking | Device: Anti-embolism Knee High Stocking<br>* Anti-embolism Knee High Compression Stocking<br>* Other names: Kendall TEDS;|
| Active Comparator: 2<br>20-30mmHg Knee High Jobst Compression Stocking | Device: 20-30 Knee High Compression Stocking<br>* 20-30 mmHg Knee High COmpression Stocking<br>* Other names: Jobst 20-30 mmHg Compression Stocking;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Edema reduction measured by bio-impedance |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Venous Severity Score Improvement in QOL |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Venous Disease, C3, Edema, Compression Garments, Compression Stockings, Bioimpedance