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.

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: SnapshotNIR imaging

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Sunny Sajjad, DPM; Phone Number: (210) 567-5131; Email: sajjad@uthscsa.edu

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • University of Texas Health Science Center at San Antonio
      • Contact: Henrik Claeson; Phone Number: 210-567-8279; Email: claeson@uthscsa.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Subjects will be enrolled through the PI's clinic population. Healthy volunteers will be recruited from the clinic staff population and other volunteers recruited from healthy clinic visitors. Subjects who are identified for study participation will be screened for all eligibility requirements. Those meeting eligibility criteria for the study will have the study explained to them by the study staff. An Informed Consent Form will be provided to sign, prior to undergoing any study procedures. Subjects will be encouraged to ask questions of the study staff. There is no cap on the number of subjects that can be screened. Additional subjects will continue to be recruited as needed to reach the total study enrollment of 250 limbs.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparing change in plantar foot NIRS measurements (baseline vs raised position) during a Provocative Maneuver Leg Raise test to the SOC clinical assessment of PAD	The significance of the relationship will be evaluated using an analysis of variance (ANOVA) where the independent variable will be the SOC assessment of PAD and the dependent variable will be the difference in NIRS measurement between the initial position (supine) and the second position (elevated leg).	1-2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparing change in plantar foot NIRS measurements (baseline vs raised position) during a Provocative Maneuver Leg Raise test paired with the presence/absence of diabetes to the SOC clinical assessment of PAD	This outcome will be evaluated using an analysis of variance (ANOVA) with two independent variables (factors) including the SOC assessment of PAD and the presence of diabetes (present or not) and the dependent variable will be the difference in NIRS measurement between the initial position (supine) and the second position (elevated leg).	1-2 days
Comparing change in dorsal foot NIRS measurements (baseline vs raised position) during a Provocative Maneuver Leg Raise test to the SOC clinical assessment of PAD	This outcome will be evaluated in a similar fashion as the analysis from the primary outcome but with the dependent variable will be calculated based on measurements taken from the dorsal surface of the foot which will be evaluated against the independent variable (SOC assessment) via ANOVA.	1-2 days
Change of NIRS measurements with other positions	This outcome will be evaluated in a similar fashion as the analysis from the primary outcome but with the dependent variable being the difference in NIRS measurement between the raised and dependent position (patient sitting up) and then the baseline and dependent position which will be evaluated against the independent variable (SOC assessment) via ANOVA.	1-2 days

Collaborators and Investigators

• Sponsor: Kent Imaging Inc
• Collaborators: The University of Texas Health Science Center at San Antonio

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: January 10, 2024
• First Submitted That Met QC Criteria: January 24, 2024
• First Posted (Actual): February 1, 2024

Study Record Updates

• Last Update Posted (Actual): October 10, 2024
• Last Update Submitted That Met QC Criteria: October 8, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: PAD; Peripheral Arterial Disease; CLI; Ankle-brachial index; Near infrared spectroscopy; NIR; Tissue Oxygen Saturation; Provocative Leg Maneuver; PAD screening
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 20230638HU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No