Using SnapshotNIR With Provocative Leg Maneuver for PAD Assessment
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: SnapshotNIR imaging.
- Who it may be relevant to
- Registry conditions: Peripheral Arterial Disease. Basic parameters: 35 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
- United States
- 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
Study to Use Change in Near Infrared Spectroscopy Assessment of Tissue Oxygenation During a Provocative Leg Maneuver to Assess Peripheral Artery Disease State.
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.
Detailed 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.
Interventions
- Device SnapshotNIR imaging
SnapshotNIR will be used for tissue oxygen-saturation imaging of all the subjects' foot along with standard of care procedures for PAD assessment.
Primary outcome measures
- Comparing change in plantar foot NIRS measurements (baseline vs raised position) during a Provocative Maneuver Leg Raise test to the SOC clinical assessment of PAD [Time frame: 1-2 days]
Secondary outcome measures (3)
- Comparing change in plantar foot NIRS measurements (baseline vs raised position) during a Provocative Maneuver Leg Raise test paired with the presence/absence of diabetes to the SOC clinical assessment of PAD [Time frame: 1-2 days]
- Comparing change in dorsal foot NIRS measurements (baseline vs raised position) during a Provocative Maneuver Leg Raise test to the SOC clinical assessment of PAD [Time frame: 1-2 days]
- Change of NIRS measurements with other positions [Time frame: 1-2 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of Texas Health Science Center at San Antonio — San Antonio
Identifiers
NCT: NCT06237621 · 20230638HU