Non-Invasive Management of Chronic Venous Insufficiency

Venous Insufficiency Clinical Trial

Official title:

Non-Invasive Management of Chronic Venous Insufficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00950378
• Other study ID #: 27610
• Secondary ID: 1R43HL092673Univ
• Status: Completed
• Phase: N/A
• First received: July 30, 2009
• Last updated: May 24, 2013
• Start date: July 2009
• Est. completion date: December 2012

Study information

• Verified date: May 2013
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 60 Years

Eligibility

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)

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Venous Insufficiency

Locations

Country	Name	City	State
United States	University of Utah Health Sciences Center	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	PhiloMetron, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

Eberhardt RT, Raffetto JD. Chronic venous insufficiency. Circulation. 2005 May 10;111(18):2398-409. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To provide device development to assess tissue changes associated with chronic venous insufficiency		two years	No
Secondary	To compare device development to existing clinical measurement		two years	No