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Compression Aided Management of Edema in Patients With C3 Venous Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00766974
Recruitment Status : Unknown
Verified October 2008 by BSN Medical Inc.
Recruitment status was:  Recruiting
First Posted : October 6, 2008
Last Update Posted : October 6, 2008
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Chronic Venous Disease Device: Anti-embolism Knee High Stocking Device: 20-30 Knee High Compression Stocking Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2008
Estimated Primary Completion Date : September 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

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 Name: 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 Name: Jobst 20-30 mmHg Compression Stocking




Primary Outcome Measures :
  1. Edema reduction measured by bio-impedance [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Clinical Venous Severity Score Improvement in QOL [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00766974


Locations
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United States, Massachusetts
Boston VA Healthcare Recruiting
West Roxbury, Massachusetts, United States, 02132
Contact: Joseph Raffetto, MD    857-203-5572    joseph.raffetto@med.va.gov   
Contact: Kathleen Hickson, RN    857-203-5572    kathleen.hickson@va.gov   
Principal Investigator: Joseph Raffetto, MD         
Sponsors and Collaborators
BSN Medical Inc
Investigators
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Principal Investigator: Joseph Raffetto, MD Boston VA Healthcare

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Responsible Party: Joseph D. Raffetto, MD, Boston VA
ClinicalTrials.gov Identifier: NCT00766974    
Other Study ID Numbers: BSNCL-0003
First Posted: October 6, 2008    Key Record Dates
Last Update Posted: October 6, 2008
Last Verified: October 2008
Keywords provided by BSN Medical Inc:
Chronic Venous Disease
C3
Edema
Compression Garments
Compression Stockings
Bioimpedance
Additional relevant MeSH terms:
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Edema
Signs and Symptoms