Non-Invasive Management of Chronic Venous Insufficiency

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00950378

Enrollment

Registered

2009-07-31

Start date

2009-07-31

Completion date

2012-12-31

Last updated

2013-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Insufficiency

Keywords

edema, blood supply, lower legs, venous stasis

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to 60 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame
To compare device development to existing clinical measurement	two years

Countries

United States

Outcome results