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

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?

Study Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Disease; Critical Limb Ischemia; Critical Lower Limb Ischemia
• Intervention / Treatment: Device: FLIR One Pro LT

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 Type: Observational
• Enrollment (Estimated): 25

Contacts and Locations

• Study Contact: Name: Jun Li, MD; Phone Number: (734) 968-5212; Email: jun.li@uhhospitals.org
• Study Contact Backup: Name: Grace Craig, DPM; Phone Number: 408 628 8102; Email: gracecraigdpm@gmail.com

Study Locations

• United States
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • Recruiting
      • University Hospitals Ahuja Medical Center
      • Sub-Investigator: Tarek Hammad, MD
      • Contact: Jun Li, MD
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals Cleveland Medical Center
      • Contact: Jun Li, MD; Phone Number: 440-882-0075; Email: Jun.Li@UHhospitals.org
      • Sub-Investigator: Tarek Hammad, MD
      • Sub-Investigator: Mehdi H Shishehbor, DO
    • Parma, Ohio, United States, 44129
      • Recruiting
      • University Hospitals Parma Medical Center
      • Sub-Investigator: Yulanka Castro, MD
      • Contact: Jun Li, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

People between ages 18 and 99 years with lower extremity peripheral artery disease with a planned endovascular intervention.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
FLIR thermal imaging group; Temperature measurements will be taken of the lower limb using the FLIR camera and correlated with other aspects of each patient.	Device: FLIR One Pro LT; Thermal imaging camera used to measure temperatures of the lower limb.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Investigators: Principal Investigator: Jun Li, MD, University Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: May 8, 2024
• First Submitted That Met QC Criteria: August 5, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2025
• Last Update Submitted That Met QC Criteria: May 8, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Chronic Limb-Threatening Ischemia; Ischemia; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: STUDY20230726

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes