Study to Use Change in Near Infrared Spectroscopy Assessment of Tissue Oxygenation During a Provocative Leg Maneuver to Assess Peripheral Artery Disease State.
Kent Imaging Inc
Summary
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
- Age range
- 35–99 years
- Sex
- All
- Healthy volunteers
- Yes
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
Interventions
- DeviceSnapshotNIR imaging
SnapshotNIR will be used for tissue oxygen-saturation imaging of all the subjects' foot along with standard of care procedures for PAD assessment.
Location
- University of Texas Health Science Center at San AntonioSan Antonio, Texas