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

HyperMed20 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Critical Limb Ischemia

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Carl T Hayden VA Medical Center

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

Assess predictive value for healing by 8 weeks of OxyVu, ABI, TBI and TCOM measured prior to amputation. OxyVu readings for oxyhemoglobin, deoxyhemoglobin and oxygen saturation will be compared to healing potential predicted from ABI, TBI, and TCOM.

Time frame: 8 weeks

Secondary Outcomes

Collect additional interventions required through review of patient medical records at 12 months

Time frame: 12 Months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.