Back to Trials
NCT06544135Recruiting

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

University Hospitals Cleveland Medical Center

Start Date

4/14/2025

Completion Date

10/1/2027

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.

Eligibility Criteria

Age Range: 18 years to 99 years

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

Interventions

DEVICE

FLIR One Pro LT

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Peripheral Arterial DiseaseCritical Limb IschemiaCritical Lower Limb Ischemia

Locations

University Hospitals Ahuja Medical Center

Beachwood, Ohio 44122

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio 44106

United States

University Hospitals Parma Medical Center

Parma, Ohio 44129

United States