Recruiting

SnapshotNIR

Sponsor:

Kent Imaging Inc

Code:

NCT06237621

Conditions

Peripheral Arterial Disease

Eligibility Criteria

Sex: All

Age: 35 - 70+

Healthy Volunteers: Accepted

Interventions

SnapshotNIR imaging

Study Details

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

Study ID

NCT06237621

Start date

Feb 12, 2024

Status verified date

Oct, 2024

Completion date

Jun, 2025

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35 - 70+

Healthy Volunteers: Accepted

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

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

People at risk of PAD

Interventions

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Sunny Sajjad, DPM

(210) 567-5131sajjad@uthscsa.edu

Locations

University of Texas Health Science Center at San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Henrik Claeson

210-567-8279claeson@uthscsa.edu

More Information

Sponsor

Kent Imaging Inc

Last update posted

Oct 10, 2024

Last verified

Oct, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Kent Imaging Inc on 2024-10-10.