Using SnapshotNIR With Provocative Leg Maneuver for PAD Assessment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-12

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Peripheral Arterial Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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People at risk of PAD

SnapshotNIR imaging

Intervention Type DEVICE

SnapshotNIR will be used for tissue oxygen-saturation imaging of all the subjects' foot along with standard of care procedures for PAD assessment.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes