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Using SnapshotNIR With Provocative Leg Maneuver for PAD Assessment

Recruiting
35 - 99 years of age
Both
Phase N/A

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Overview

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.

Description

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.

Eligibility

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

Study details

Peripheral Arterial Disease

NCT06237621

Kent Imaging Inc

16 February 2024

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