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

Near Infrared Spectroscopy Imaging of Change in Tissue Oxygenation During a Provocative Leg Elevation Maneuver to Assess Peripheral Artery Disease: A Multicenter Study.

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07397494

Enrollment

200

Registered

2026-02-09

Start date

2026-03-01

Completion date

2027-12-01

Last updated

2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease

Keywords

SnapshotNIR, PAD, NIR

Brief summary

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.

Interventions

OTHERObservational study only.

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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to 99 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026