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Non-Invasive Management of Chronic Venous Insufficiency

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00950378
First Posted: July 31, 2009
Last Update Posted: May 29, 2013
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.
Collaborator:
PhiloMetron, Inc.
Information provided by (Responsible Party):
University of Utah
  Purpose

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.


Condition
Venous Insufficiency

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Non-Invasive Management of Chronic Venous Insufficiency

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • To provide device development to assess tissue changes associated with chronic venous insufficiency [ Time Frame: two years ]

Secondary Outcome Measures:
  • To compare device development to existing clinical measurement [ Time Frame: two years ]

Enrollment: 10
Study Start Date: July 2009
Study Completion Date: December 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
CVI
Varicose veins, varicose veins with leg swelling, venous stasis skin color changes, no open ulcers
No treatment
Subjects with no venous disease CEAP (clinical etiology antomy pathophysiology)Class 0

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
CVI subjects will be recruited from University of Utah vascular surgery service.Control group will be recruited from the community.
Criteria

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)
  Contacts and Locations
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): NCT00950378


Locations
United States, Utah
University of Utah Health Sciences Center
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
PhiloMetron, Inc.
Investigators
Principal Investigator: Harriet Hopf, MD University of Utah
  More Information

Publications:
Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT00950378     History of Changes
Other Study ID Numbers: 27610
1R43HL092673 ( U.S. NIH Grant/Contract )
University of Utah ( Other Grant/Funding Number: 54901268 )
First Submitted: July 30, 2009
First Posted: July 31, 2009
Last Update Posted: May 29, 2013
Last Verified: May 2013

Keywords provided by University of Utah:
edema
blood supply
lower legs
venous stasis

Additional relevant MeSH terms:
Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases