Non-Invasive Management of Chronic Venous Insufficiency

NCT ID: NCT00950378

Last Updated: 2013-05-29

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-31

Study Completion Date

2012-12-31

Brief Summary

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The purpose of this study is:

-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.

Detailed Description

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Conditions

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Venous Insufficiency

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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 CVI with CEAP class 4 or higher
* participants with no CVI class 0

Exclusion Criteria

* open ulcers or lower extremity amputation
* 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)
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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PhiloMetron, Inc.

INDUSTRY

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

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.

Reference Type BACKGROUND
PMID: 15883226 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10355863 (View on PubMed)

Other Identifiers

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1R43HL092673

Identifier Type: NIH

Identifier Source: secondary_id

View Link

University of Utah

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

27610

Identifier Type: -

Identifier Source: org_study_id

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