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

Clinical Validation of HyperMed OxyVu Tissue Oximeter for Assessing Level of Amputation With Comparison to Other Modalities

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.

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.

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.