Overview
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.
Description
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.
Eligibility
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