Using SnapshotNIR With Provocative Leg Maneuver for PAD Assessment

Part of paid clinical trials in San Antonio, Texas.

Sponsor
Kent Imaging Inc
Study ID
NCT06237621
Status
Recruiting
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Conditions

  • Peripheral Arterial Disease

Eligibility Criteria

Sex
ALL
Age
35 Years - 99 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Feb 12, 2024
Status verified
Oct 2024
Primary completion
Dec 31, 2024
Completion
Jun 30, 2025

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: People at risk of PAD

Primary Outcome Measure

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 [ Time Frame: 1-2 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Health Science Center at San AntonioSan AntonioTexas78229
Henrik Claeson
[email protected]
210-567-8279

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By research site
University of Texas Health Science Center at San Antonio· San Antonio, TX

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