NCT06237621RecruitingAccepts Healthy Volunteers
Using SnapshotNIR With Provocative Leg Maneuver for PAD Assessment
Kent Imaging Inc
Start Date
2/12/2024
Completion Date
6/1/2025
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.
Detailed 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 Criteria
Age Range: 35 years to 99 years
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
DEVICE
SnapshotNIR imaging
Conditions
Peripheral Arterial Disease
Locations
University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
United States