Using SnapshotNIR With Provocative Leg Maneuver for PAD Assessment

NCT06237621 | Recruiting FDA Device

• 1 other identifier: 20230638HU
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease

Keywords

Ankle-brachial index; Tissue Oxygen Saturation; Near infrared spectroscopy; NIR; Peripheral Arterial Disease; PAD; CLI; Provocative Leg Maneuver; PAD screening

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (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

  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

Study Arms (1)

People at risk of PAD

Device: SnapshotNIR imaging

Interventions

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.

People at risk of PAD

Eligibility Criteria

• Age: 35 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• years of age
• Subject has at least 1 intact forefoot
• Can achieve leg positions to complete the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Kent Imaging Inc: lead
• The University of Texas Health Science Center at San Antonio: collaborator

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Central Study Contacts

Sunny Sajjad, DPM

CONTACT

(210) 567-5131; sajjad@uthscsa.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: February 1, 2024
• Study Start: February 12, 2024
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)