Non-Invasive Management of Chronic Venous Insufficiency

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.

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Key information

Conditions

Venous Insufficiency Cardiovascular Diseases Edema Leg Ulcer Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Ulcer Varicose Veins Vascular Diseases

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Utah Health Sciences Center

Salt Lake City, Utah, 84132, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

PhiloMetron, Inc.

Registry information

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2012
First posted: Jul 31, 2009
Registry last updated: May 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed