Non-Invasive Management of Chronic Venous Insufficiency

Completed

• Conditions: Venous Insufficiency

• Registration Number: NCT00950378
• Lead Sponsor: University of Utah

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-30
• Study First Submitted QC: 2009-07-30
• Study First Posted: 2009-07-31
• Primary Completion: 2012-08
• Study Completion: 2012-12
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-24
• Last Update Posted: 2013-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To provide device development to assess tissue changes associated with chronic venous insufficiency	two years

Secondary Outcome Measures

Name	Time	Method
To compare device development to existing clinical measurement	two years

Trial Locations

Locations (1)

University of Utah Health Sciences Center; 🇺🇸 Salt Lake City, Utah, United States