Near Infrared Spectroscopy Imaging of Change in Tissue Oxygenation to Assess Peripheral Artery Disease

Sponsor
Kent Imaging Inc
Study ID
NCT07397494
Status
Not Yet Recruiting

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Conditions

  • Peripheral Arterial Disease

Eligibility Criteria

Sex
ALL
Age
21 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Observational study only. — OTHER
    Observational study only. All data collection will be completely observational and will not affect the patient care and treatment plan by any means.

Study Details

This is a proof-of-concept study with exploratory objective to assess whether superficial tissue oxygenation patterns measured by Snapshot NIRS, in conjunction with the Provocative Elevation Maneuver of the Lower Extremity (PEMLE) and/or the Plantar Palmar Index (PPI), are associated with the severity of peripheral arterial disease (PAD) as determined by standard of care assessments and can be used to assess tissue oxygenation after revascularization, where applicable.

Key Dates

First listed
Feb 9, 2026
Start date
Mar 31, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: Suspected of PAD
    subjects suspected of PAD

Primary Outcome Measure

To characterize superficial tissue oxygenation patterns, as measured by Snapshot NIRS, in patients with suspected or confirmed peripheral arterial disease (PAD). [ Time Frame: baseline ]

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