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Non-Invasive Management of Chronic Venous Insufficiency

This study has been completed.
Sponsor:
Collaborator:
PhiloMetron, Inc.
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT00950378
First received: July 30, 2009
Last updated: May 24, 2013
Last verified: May 2013
History of Changes
  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

Resource links provided by NLM:

MedlinePlus related topics: Edema
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare device development to existing clinical measurement [ Time Frame: two years ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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, 1 R43 HL 092673, University of Utah
Study First Received: July 30, 2009
Last Updated: May 24, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013