Compression Aided Management of Edema in Patients With C3 Venous Disease

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00766974
• Other study ID #: BSNCL-0003
• Status: Recruiting
• Phase: Phase 4
• First received: October 3, 2008
• Last updated: October 3, 2008
• Start date: October 2008
• Est. completion date: December 2009

Study information

• Verified date: October 2008
• Source: BSN Medical Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Venous Disease

Intervention

Device:
• Anti-embolism Knee High Stocking
Anti-embolism Knee High Compression Stocking
• 20-30 Knee High Compression Stocking
20-30 mmHg Knee High COmpression Stocking

Locations

Country	Name	City	State
United States	Boston VA Healthcare	West Roxbury	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
BSN Medical Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Edema reduction measured by bio-impedance		4 weeks	No
Secondary	Clinical Venous Severity Score Improvement in QOL		4 weeks	No