Near Infrared Spectroscopy Imaging of Change in Tissue Oxygenation to Assess Peripheral Artery Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Observational study only..
- Who it may be relevant to
- Registry conditions: Peripheral Arterial Disease. Basic parameters: 21 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Near Infrared Spectroscopy Imaging of Change in Tissue Oxygenation During a Provocative Leg Elevation Maneuver to Assess Peripheral Artery Disease: A Multicenter Study.
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.
Interventions
- Other Observational 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.
Primary outcome measures
- To characterize superficial tissue oxygenation patterns, as measured by Snapshot NIRS, in patients with suspected or confirmed peripheral arterial disease (PAD). [Time frame: baseline]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07397494 · K2024-02