RecruitingNCT06237621

Using SnapshotNIR With Provocative Leg Maneuver for PAD Assessment

Study to Use Change in Near Infrared Spectroscopy Assessment of Tissue Oxygenation During a Provocative Leg Maneuver to Assess Peripheral Artery Disease State.


Sponsor

Kent Imaging Inc

Enrollment

150 participants

Start Date

Feb 12, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 35 YearsMax Age: 99 Years

Inclusion Criteria3

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

Exclusion Criteria6

  • 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

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Interventions

DEVICESnapshotNIR imaging

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


Locations(1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

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NCT06237621


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