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

N/ANot Yet RecruitingNCT07397494

Kent Imaging Inc200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Peripheral Arterial Disease

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.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects between the ages of 21 and 99 years inclusive at the time of screening referred to the investigative site for further evaluation of known/suspected PAD. * Subject has at least 1 intact forefoot. * Can achieve leg positions as specified in the protocol to complete the study. * Willing and able to provide written consent and adhere to protocol requirements Exclusion Criteria: * The subject is unwilling or unable to comply with the protocol (including but not limited to ability to tolerate leg lift) or scheduled appointments. * The subject has had higher than trans metatarsal amputation on both limbs. * Subjects who are pregnant, nursing or plan to become pregnant. * For any reason as deemed appropriate by the Principal Investigator to be unsuitable for the study.

Outcomes

Primary Outcomes

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

To characterize superficial tissue oxygenation patterns, as measured by Snapshot NIRS, in patients with suspected or confirmed peripheral arterial disease (PAD). PEMLE and PPI will be performed during the NIR assessment to support exploratory correlation with oxygenation patterns.

Time frame: baseline

Data from ClinicalTrials.gov

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