RECRUITINGOBSERVATIONAL
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.
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 35-99 years of age
- Subject has at least 1 intact forefoot
- Can achieve leg positions to complete the study
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DEVICE
SnapshotNIR imaging
SnapshotNIR will be used for tissue oxygen-saturation imaging of all the subjects' foot along with standard of care procedures for PAD assessment.
Locations (1)
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States