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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suspected of PAD | subjects suspected of PAD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will be identified and enrolled through the PI's routine clinic population. Subjects who are identified for study participation will be screened for all eligibility requirements. Those meeting eligibility criteria for the study will have the study explained to them by the Principal investigator and have the opportunity to ask questions. An Informed Consent Form (ICF) will be signed prior to subjects undergoing any study procedures. Subjects will be encouraged to ask the study staff questions about the study.
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |