Study to Use Change in Near Infrared Spectroscopy Assessment of Tissue Oxygenation During a Provocative Leg Maneuver to Assess Peripheral Artery Disease State.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Arterial Disease
- Sponsor
- Kent Imaging Inc
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
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
Outcomes
Primary Outcomes
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
The significance of the relationship will be evaluated using an analysis of variance (ANOVA) where the independent variable will be the SOC assessment of PAD and the dependent variable will be the difference in NIRS measurement between the initial position (supine) and the second position (elevated leg).
Secondary Outcomes
- 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(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(1-2 days)
- Change of NIRS measurements with other positions(1-2 days)