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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014