CompletedNot Applicable

Non-Invasive Management of Chronic Venous Insufficiency

United States10 participantsStarted 2009-07

Plain-language 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.

Who can participate

Age range40 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

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

Timeframe: two years

Trial details

NCT IDNCT00950378

SponsorUniversity of Utah

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2012-08

View on ClinicalTrials.gov More Venous Insufficiency trials