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| Name | Class |
|---|---|
| The University of Texas Health Science Center at San Antonio | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| People at risk of PAD |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SnapshotNIR imaging | Device | SnapshotNIR will be used for tissue oxygen-saturation imaging of all the subjects' foot along with standard of care procedures for PAD assessment. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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). | 1-2 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | This outcome will be evaluated using an analysis of variance (ANOVA) with two independent variables (factors) including the SOC assessment of PAD and the presence of diabetes (present or not) and the dependent variable will be the difference in NIRS measurement between the initial position (supine) and the second position (elevated leg). |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will be enrolled through the PI's clinic population. Healthy volunteers will be recruited from the clinic staff population and other volunteers recruited from healthy clinic visitors. 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 study staff. An Informed Consent Form will be provided to sign, prior to undergoing any study procedures. Subjects will be encouraged to ask questions of the study staff. There is no cap on the number of subjects that can be screened. Additional subjects will continue to be recruited as needed to reach the total study enrollment of 250 limbs.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sunny Sajjad, DPM | Contact | (210) 567-5131 | sajjad@uthscsa.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center at San Antonio | Recruiting | San Antonio | Texas | 78229 | United States |
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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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| 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 | This outcome will be evaluated in a similar fashion as the analysis from the primary outcome but with the dependent variable will be calculated based on measurements taken from the dorsal surface of the foot which will be evaluated against the independent variable (SOC assessment) via ANOVA. | 1-2 days |
| Change of NIRS measurements with other positions | This outcome will be evaluated in a similar fashion as the analysis from the primary outcome but with the dependent variable being the difference in NIRS measurement between the raised and dependent position (patient sitting up) and then the baseline and dependent position which will be evaluated against the independent variable (SOC assessment) via ANOVA. | 1-2 days |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |