NCT06544135

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 25 (estimated)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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?

Detailed 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.

Conditions

• Peripheral Arterial Disease
• Critical Limb Ischemia
• Critical Lower Limb Ischemia

Interventions

Type	Name	Description
DEVICE	FLIR One Pro LT	Thermal imaging camera used to measure temperatures of the lower limb.

Timeline

• Start date: 2025-04-14
• Primary completion: 2027-10-01
• Completion: 2027-10-01
• First posted: 2024-08-09
• Last updated: 2025-05-13

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study