Using SnapshotNIR With Provocative Leg Maneuver for PAD Assessment

Study to Use Change in Near Infrared Spectroscopy Assessment of Tissue Oxygenation During a Provocative Leg Maneuver to Assess Peripheral Artery Disease State.

The objective of this trial is to determine if Near-infrared spectroscopy (NIRS) can accurately evaluate the degree of Peripheral Arterial Disease (PAD) during a Provocative Elevation Maneuver of the Lower Extremity (PEMLE) test, as compared to routine clinical assessments.

This study is designed as a prospective observational study to assess the effectiveness of NIRS to accurately evaluate the degree of PAD, as compared to routine clinical assessment, during the PEMLE test protocol. This will be a single visit study where subjects will be screened and enrolled during a regular clinic visit.

Inclusion Criteria:

• 35-99 years of age
• Subject has at least 1 intact forefoot
• Can achieve leg positions to complete the study

Exclusion Criteria:

• The subject is unwilling or unable to comply with the protocol or scheduled appointments.
• The subject has had transmetatarsal amputation or higher on both limbs.
• Vascular intervention within the past year
• Subjects who have had a previous distal bypass procedure
• Pregnant or plans to become pregnant
• Deemed by the PI to be unsuitable for the study