Using SnapshotNIR With Provocative Leg Maneuver for PAD Assessment

Purpose

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.

Condition

  • Peripheral Arterial Disease

Eligibility

Eligible Ages
Between 35 Years and 99 Years
Eligible Genders
All
Accepts 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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
People at risk of PAD
  • 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.

Recruiting Locations

University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
Contact:
Henrik Claeson
210-567-8279
claeson@uthscsa.edu

More Details

Status
Recruiting
Sponsor
Kent Imaging Inc

Study Contact

Sunny Sajjad, DPM
(210) 567-5131
sajjad@uthscsa.edu

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.