Using SnapshotNIR With Provocative Leg Maneuver for PAD Assessment
Purpose
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.
Condition
- Peripheral Arterial Disease
Eligibility
- Eligible Ages
- Between 35 Years and 99 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| People at risk of PAD |
|
Recruiting Locations
University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
San Antonio, Texas 78229
More Details
- Status
- Recruiting
- Sponsor
- Kent Imaging Inc
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.