Using SnapshotNIR With Provocative Leg Maneuver for PAD Assessment

Recruiting

• Conditions: Peripheral Arterial Disease
• Interventions: Device: SnapshotNIR imaging

• Registration Number: NCT06237621
• Lead Sponsor: Kent Imaging Inc

Brief 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.

Study Timeline

• Study First Submitted: 2024-01-10
• Study First Submitted QC: 2024-01-24
• Study First Posted: 2024-02-01
• Study Start: 2024-02-12
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-10
• Primary Completion: 2024-12
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
People at risk of PAD	SnapshotNIR imaging	-

Primary Outcome Measures

Name	Time	Method
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	1-2 days	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).

Secondary Outcome Measures

Name	Time	Method
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	1-2 days	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).
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	1-2 days	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.
Change of NIRS measurements with other positions	1-2 days	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.

Trial Locations

Locations (1)

University of Texas Health Science Center at San Antonio; 🇺🇸 San Antonio, Texas, United States