Validation of OxyVu for Assessing Level of Amputation With Comparison to Other Modalities (LOA)

HyperMed Imaging

Status: Unknown

Conditions: Critical Limb Ischemia

Study type: Observational

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT00767923

2008-011

Details and patient eligibility

About

Correlation of(OxyVu) values to to ABI, TBP, and TCOM in patients scheduled for foot level amputation because of critical limb ischemia, infection, or tissue necrosis.

Full description

The purpose of this clinical study is to correlate tissue oxygenation values measured with a hyperspectral imaging system (OxyVu) to Ankle Brachial Indices (ABI), toe pressures (TBP), and transcutaneous oxygen monitoring (TCOM) in patients scheduled for foot level amputation because of critical limb ischemia, infection, or tissue necrosis.

Enrollment: 20 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 18 to 85 years of age, males and females, varying skin tones, varying racial origins, and with and without diabetes.
• Patients scheduled for foot level amputation because of critical limb ischemia, infection, or tissue necrosis.