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

Recruiting

• Conditions: Peripheral Arterial Disease; Critical Limb Ischemia; Critical Lower Limb Ischemia
• Interventions: Device: FLIR One Pro LT

• Registration Number: NCT06544135
• Lead Sponsor: University Hospitals Cleveland Medical Center

Brief 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.

Study Timeline

• Study First Submitted: 2024-05-08
• Study First Submitted QC: 2024-08-05
• Study First Posted: 2024-08-09
• Study Start: 2025-04-14
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-13
• Primary Completion: 2027-10
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
FLIR thermal imaging group	FLIR One Pro LT	Temperature measurements will be taken of the lower limb using the FLIR camera and correlated with other aspects of each patient.

Primary Outcome Measures

Name	Time	Method
Change in ABI	Up to 90 days before revascularization; Up to 1 year after revascularization	Ankle brachial index will be taken before and after intervention and correlated with thermal readings from FLIR.

Secondary Outcome Measures

Name	Time	Method
Mortality	Up to 1 year after revascularization	Subject deaths during the length of the study
Major amputations	Up to 1 year after revascularization	Any associated amputations the subject had after revascularization
Major revascularizations post-initial intervention	Up to 1 year after revascularization	Any revascularization procedures done after the initial revascularization

Trial Locations

Locations (3)

University Hospitals Ahuja Medical Center; 🇺🇸 Beachwood, Ohio, United States

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States

University Hospitals Parma Medical Center; 🇺🇸 Parma, Ohio, United States