Chronic Venous Disease Clinical Trial
Official title:
Compression Versus Anti-Embolism Stockings in Patients With Leg Edema: Objective Investigation of Interface Compression and Edema Measurements, Clinical Outcomes, and Quality of Life.
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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