Non-Invasive Management of Chronic Venous Insufficiency

University of Utah10 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Venous Insufficiency

Eligibility

Sex: ALLMin age: 40 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

University of Utah Health Sciences Center

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

To provide device development to assess tissue changes associated with chronic venous insufficiency

Time frame: two years

Secondary Outcomes

To compare device development to existing clinical measurement

Time frame: two years

Data from ClinicalTrials.gov

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