FlowMet-R Blood Flow Measurement for the Diagnosis of Peripheral Artery Disease and Critical Limb Ischemia

FlowMet-R Blood Flow Measurement for the Diagnosis of Peripheral Artery Disease (PAD) and Critical Limb Ischemia (CLI)

Non-randomized, multi-center, longitudinal study of healthy subjects and subjects with PAD who are scheduled for ABI, TBI, and either Duplex Ultrasound or Angiographic assessments in a vascular clinic.

Patients scheduled for peripheral vascular examination and healthy controls will be measured with the FlowMet-R, a noninvasive blood flow monitor, and compared to gold standard diagnostics - ABI, TBI, and Doppler Ultrasound. Sensitivity and specificity of the FlowMet-R device output in diagnosing PAD and CLI will be assessed on initial visit, 3-month followup, and 6-month followup.

Inclusion Criteria:

PAD Positive Cohort

• Subject meets PAD positive criteria
• Subject is willing and able to provide informed consent
• Subject is willing and able to comply with study procedures
• Subject is able to understand the study procedures
• Subject is scheduled for vascular examination that includes noninvasive assessments as standard of care: ABI, TBI, and either a Duplex Ultrasound or Angiogram

Healthy Cohort

• Subject is willing and able to provide informed consent.
• Subject is willing and able to comply with the study procedures.
• Subject is able to understand the study procedures.
• Subject has no history of positive PAD diagnosis, and is not currently suspected of having PAD.

Exclusion Criteria:

PAD Positive Cohort

• Subject is under 40 or unable to consent.
• Subject has any medical condition, which, in the judgment of the Investigator and/or designee, makes the subject a poor candidate for the investigational study.
• Subject is excluded from analysis if no stenosis is found during Doppler but Tibial disease is suspected and Tibial ultrasound is not able to be performed.
• Subject does not have a suitable finger to attach the FlowMet-R probe.
• Subject does not have a suitable 1st or 2nd digit to attach FlowMet-R probe on the limb of interest.
• Subject has undergone revascularization within the last 90 days
• Subject cannot lay safely in a supine position.

Healthy Cohort

• Subject is under 40 or unable to consent.
• Subject has any medical condition, which, in the judgment of the Investigator and/or designee, makes the subject a poor candidate for the investigational study.
• One or more limbs has a prior or current diagnosis of PAD, or is reasonably suspected of having a diagnosis of PAD.
• Subject does not have a suitable finger to attach the FlowMet-R probe.
• Subject does not have a suitable 1st or 2nd digit to attach FlowMet-R probe.
• Subject has undergone revascularization within the last 90 days