Use of Thermal Imaging Camera to Assess Perfusion Before and After Vascular Intervention (TIC)

University Hospitals (UH)

Status: Begins enrollment this month

Conditions: Critical Limb Ischemia; Critical Lower Limb Ischemia; Peripheral Arterial Disease

Treatments: Device: FLIR One Pro LT

Study type: Observational

Funder types: Other

Identifiers

NCT06544135

STUDY20230726

Details and patient eligibility

About

This is a preliminary prospective observational study measuring change in lower extremity temperature in response to revascularization procedure.

The main question this study aims to answer is:

• Are temperature measurements from a forward looking infrared (FLIR) camera of the lower extremity useful in predicting outcome of revascularization procedures?

Full description

This is a preliminary prospective observational study measuring change in lower extremity temperature in response to revascularization procedure.

Patients with lower extremity PAD will be seen in office pre-intervention. Consent to participate in the TIC study will be acquired at this point. Patients will be given a physical copy of their consent form at the time consent is obtained. During this initial visit or subsequent pre-procedural office visit, the smartphone-based thermal camera will be utilized to measure the temperature of the lower extremity foot, ankle, and leg at the plantar, dorsal, and lateral distributions. Comorbidities and demographic factors will be documented from medical records at this time as well.

Data will be gathered at a consistent location to minimize impact of room temperature on measurements.

Patients will then undergo scheduled revascularization with the interventionist.

Post-intervention pictures will be taken immediately after revascularization.

Patients will then be seen again by the research team for follow-up thermal camera imaging, 1 week post-intervention, and weekly post intervention for at least 1 month but up to 6 months.

Thermal measurements will be correlated with intra-op imaging and clinical outcomes in data analysis.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Lower extremity peripheral artery disease with tissue loss consistent with Rutherford classification V or VI.
• Planned lower extremity endovascular intervention

Exclusion criteria

• Non-arterial ulcers
• Pregnant

Trial design

25 participants in 1 patient group

FLIR thermal imaging group

Description:

Temperature measurements will be taken of the lower limb using the FLIR camera and correlated with other aspects of each patient.

Treatment:

Device: FLIR One Pro LT