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Using SnapshotNIR for PAD Assessment

This study is looking at whether a device called SnapshotNIR can accurately check for Peripheral Arterial Disease (PAD) during a leg raise test. PAD is a condition where narrowed arteries reduce blood flow to your limbs. SnapshotNIR uses near-infrared light to measure oxygen levels in your foot. Researchers will compare these measurements to standard ways doctors assess PAD. You might be able to join if you are between 35 and 99 years old, have at least one intact forefoot, and can move your legs into different positions for the test. The study aims to see if the SnapshotNIR measurements change when your leg is raised, and if these changes match what doctors usually find. The study is currently unclear on its recruitment status.

Study design
This is an observational study planning to include 150 participants. It will compare SnapshotNIR measurements to standard clinical assessments.
What's involved
You would have a single visit where SnapshotNIR imaging of your foot will be done along with standard PAD assessments.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 1-2 days after baseline.

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NCT06237621

Using SnapshotNIR With Provocative Leg Maneuver for PAD Assessment

Recruiting
Not specifiedAges 35–99Observational
Kent Imaging Inc
~150 participants
Updated 2024-10-10 on ClinicalTrials.gov
What's tested:SnapshotNIR imaging

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over 1-2 days

Conditions

Peripheral Arterial Disease

Explore related trials

Chronic Limb-Threatening IschemiaPeripheral Artery Disease

Where it's being run

1 sites across 1 states
Texas1

Who to contact

Sunny Sajjad, DPM
[email protected]
(210) 567-5131
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

35-99 years of age
Subject has at least 1 intact forefoot
Can achieve leg positions to complete the study

Exclusion

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

What this trial measures

  • Comparing change in plantar foot NIRS measurements (baseline vs raised position) during a Provocative Maneuver Leg Raise test to the SOC clinical assessment of PAD1-2 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).