Using SnapshotNIR With Provocative Leg Maneuver for PAD Assessment

Peripheral Arterial Disease Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06237621
• Other study ID #: 20230638HU
• Status: Recruiting
• Start date: January 2024
• Est. completion date: June 2025

Study information

• Verified date: January 2024
• Source: Kent Imaging Inc
• Contact: Sunny Sajjad, DPM
• Phone: (210) 567-5131
• Email: sajjad[@]uthscsa.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Kent Imaging Inc	The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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).	1-2 days
Secondary	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
Secondary	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