Compression Aided Management of Edema in Patients With C3 Venous Disease

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Venous Disease
• Intervention / Treatment: Device: Anti-embolism Knee High Stocking; Device: 20-30 Knee High Compression Stocking

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • West Roxbury, Massachusetts, United States, 02132
      • Recruiting
      • Boston VA Healthcare
      • Contact: Joseph Raffetto, MD; Phone Number: 857-203-5572; Email: joseph.raffetto@med.va.gov
      • Contact: Kathleen Hickson, RN; Phone Number: 857-203-5572; Email: kathleen.hickson@va.gov
      • Principal Investigator: Joseph Raffetto, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 1; Anti-embolism Knee High compression stocking	Device: Anti-embolism Knee High Stocking; Anti-embolism Knee High Compression Stocking; Other Names: Kendall TEDS
ACTIVE_COMPARATOR: 2; 20-30mmHg Knee High Jobst Compression Stocking	Device: 20-30 Knee High Compression Stocking; 20-30 mmHg Knee High COmpression Stocking; Other Names: Jobst 20-30 mmHg Compression Stocking

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: BSN Medical Inc
• Investigators: Principal Investigator: Joseph Raffetto, MD, Boston VA Healthcare

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (ANTICIPATED): September 1, 2009
• Study Completion (ANTICIPATED): December 1, 2009

Study Registration Dates

• First Submitted: October 3, 2008
• First Submitted That Met QC Criteria: October 3, 2008
• First Posted (ESTIMATE): October 6, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): October 6, 2008
• Last Update Submitted That Met QC Criteria: October 3, 2008
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Keywords: Edema; Bioimpedance; Chronic Venous Disease; Compression Stockings; C3; Compression Garments
• Additional Relevant MeSH Terms: Edema
• Other Study ID Numbers: BSNCL-0003