Compression Aided Management of Edema in Patients With C3 Venous Disease
- Conditions
- Chronic Venous Disease
- Interventions
- Device: Anti-embolism Knee High StockingDevice: 20-30 Knee High Compression Stocking
- Registration Number
- NCT00766974
- Lead Sponsor
- BSN Medical Inc
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- Patients with varicose veins exhibiting lower leg edema
- Unilateral or bi-lateral edema
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Anti-embolism Knee High Stocking Anti-embolism Knee High compression stocking 2 20-30 Knee High Compression Stocking 20-30mmHg Knee High Jobst Compression Stocking
- Primary Outcome Measures
Name Time Method Edema reduction measured by bio-impedance 4 weeks
- Secondary Outcome Measures
Name Time Method Clinical Venous Severity Score Improvement in QOL 4 weeks
Trial Locations
- Locations (1)
Boston VA Healthcare
🇺🇸West Roxbury, Massachusetts, United States