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Compression Aided Management of Edema in Patients With C3 Venous Disease

Primary Purpose

Chronic Venous Disease

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Anti-embolism Knee High Stocking
20-30 Knee High Compression Stocking
Sponsored by
BSN Medical Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Venous Disease focused on measuring Chronic Venous Disease, C3, Edema, Compression Garments, Compression Stockings, Bioimpedance

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boston VA HealthcareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Anti-embolism Knee High compression stocking

20-30mmHg Knee High Jobst Compression Stocking

Outcomes

Primary Outcome Measures

Edema reduction measured by bio-impedance

Secondary Outcome Measures

Clinical Venous Severity Score Improvement in QOL

Full Information

First Posted
October 3, 2008
Last Updated
October 3, 2008
Sponsor
BSN Medical Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00766974
Brief Title
Compression Aided Management of Edema in Patients With C3 Venous Disease
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Unknown status
Study Start Date
October 2008 (undefined)
Primary Completion Date
September 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
BSN Medical Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Venous Disease
Keywords
Chronic Venous Disease, C3, Edema, Compression Garments, Compression Stockings, Bioimpedance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Anti-embolism Knee High compression stocking
Arm Title
2
Arm Type
Active Comparator
Arm Description
20-30mmHg Knee High Jobst Compression Stocking
Intervention Type
Device
Intervention Name(s)
Anti-embolism Knee High Stocking
Other Intervention Name(s)
Kendall TEDS
Intervention Description
Anti-embolism Knee High Compression Stocking
Intervention Type
Device
Intervention Name(s)
20-30 Knee High Compression Stocking
Other Intervention Name(s)
Jobst 20-30 mmHg Compression Stocking
Intervention Description
20-30 mmHg Knee High COmpression Stocking
Primary Outcome Measure Information:
Title
Edema reduction measured by bio-impedance
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Clinical Venous Severity Score Improvement in QOL
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Raffetto, MD
Organizational Affiliation
Boston VA Healthcare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston VA Healthcare
City
West Roxbury
State/Province
Massachusetts
ZIP/Postal Code
02132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Raffetto, MD
Phone
857-203-5572
Email
joseph.raffetto@med.va.gov
First Name & Middle Initial & Last Name & Degree
Kathleen Hickson, RN
Phone
857-203-5572
Email
kathleen.hickson@va.gov
First Name & Middle Initial & Last Name & Degree
Joseph Raffetto, MD

12. IPD Sharing Statement

Learn more about this trial

Compression Aided Management of Edema in Patients With C3 Venous Disease

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