Compression Aided Management of Edema in Patients With C3 Venous Disease
NCT ID: NCT00766974
Last Updated: 2008-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
40 participants
INTERVENTIONAL
2008-10-31
2009-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Anti-embolism Knee High compression stocking
Anti-embolism Knee High Stocking
Anti-embolism Knee High Compression Stocking
2
20-30mmHg Knee High Jobst Compression Stocking
20-30 Knee High Compression Stocking
20-30 mmHg Knee High COmpression Stocking
Interventions
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Anti-embolism Knee High Stocking
Anti-embolism Knee High Compression Stocking
20-30 Knee High Compression Stocking
20-30 mmHg Knee High COmpression Stocking
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Unilateral or bi-lateral edema
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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BSN Medical Inc
INDUSTRY
Responsible Party
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Boston VA
Principal Investigators
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Joseph Raffetto, MD
Role: PRINCIPAL_INVESTIGATOR
Boston VA Healthcare
Locations
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Boston VA Healthcare
West Roxbury, Massachusetts, United States
Countries
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Facility Contacts
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Joseph Raffetto, MD
Role: primary
Kathleen Hickson, RN
Role: backup
Other Identifiers
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BSNCL-0003
Identifier Type: -
Identifier Source: org_study_id