Non-Invasive Management of Chronic Venous Insufficiency
NCT ID: NCT00950378
Last Updated: 2013-05-29
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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COMPLETED
10 participants
OBSERVATIONAL
2009-07-31
2012-12-31
Brief Summary
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-item one to use two new non-invasive technologies to evaluate scarring and swelling associated with chronic venous insufficiency.
The study hypothesis:
\- item one non-invasive technologies can provide a tool for assessing risk of ulcer development based on the tissue edema and alteration.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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CVI
Varicose veins, varicose veins with leg swelling, venous stasis skin color changes, no open ulcers
No interventions assigned to this group
No treatment
Subjects with no venous disease CEAP (clinical etiology antomy pathophysiology)Class 0
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* participants with no CVI class 0
Exclusion Criteria
* diabetics with HbA1C greater than 7.0
* arterial occlusive disease
* BMI greater than 35
* any connective tissue disorder (lipodermatosclerosis and fibrosis)
* participants with metallic prosthesis or implants
* participants with renal impairment
* pregnancy
* inability or refusal to wear compression stockings prescribed by physician (CVI patients only)
40 Years
60 Years
ALL
Yes
Sponsors
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PhiloMetron, Inc.
INDUSTRY
University of Utah
OTHER
Responsible Party
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Principal Investigators
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Harriet Hopf, MD
Role: PRINCIPAL_INVESTIGATOR
University of Utah
Locations
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University of Utah Health Sciences Center
Salt Lake City, Utah, United States
Countries
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References
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Eberhardt RT, Raffetto JD. Chronic venous insufficiency. Circulation. 2005 May 10;111(18):2398-409. doi: 10.1161/01.CIR.0000164199.72440.08. No abstract available.
Olin JW, Beusterien KM, Childs MB, Seavey C, McHugh L, Griffiths RI. Medical costs of treating venous stasis ulcers: evidence from a retrospective cohort study. Vasc Med. 1999;4(1):1-7. doi: 10.1177/1358836X9900400101.
Other Identifiers
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University of Utah
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
27610
Identifier Type: -
Identifier Source: org_study_id
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