Non-Invasive Management of Chronic Venous Insufficiency

Utah System of Higher Education (USHE)

Status: Completed

Conditions: Venous Insufficiency

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00950378

University of Utah (Other Grant/Funding Number)

1R43HL092673 (U.S. NIH Grant/Contract)

27610

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 40 to 60 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

10 participants in 2 patient groups

CVI

Description:

Varicose veins, varicose veins with leg swelling, venous stasis skin color changes, no open ulcers

No treatment

Description:

Subjects with no venous disease CEAP (clinical etiology antomy pathophysiology)Class 0