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

NCT ID: NCT06544135

Last Updated: 2025-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-14

Study Completion Date

2027-10-31

Brief Summary

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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

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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

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Peripheral Arterial Disease Critical Limb Ischemia Critical Lower Limb Ischemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

FLIR One Pro LT

Intervention Type DEVICE

Thermal imaging camera used to measure temperatures of the lower limb.

Interventions

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FLIR One Pro LT

Thermal imaging camera used to measure temperatures of the lower limb.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospitals Cleveland Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jun Li, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals

Locations

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University Hospitals Ahuja Medical Center

Beachwood, Ohio, United States

Site Status RECRUITING

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Site Status RECRUITING

University Hospitals Parma Medical Center

Parma, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jun Li, MD

Role: CONTACT

(734) 968-5212

Grace Craig, DPM

Role: CONTACT

408 628 8102

Facility Contacts

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Jun Li, MD

Role: primary

Jun Li, MD

Role: primary

440-882-0075

Jun Li, MD

Role: primary

Other Identifiers

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STUDY20230726

Identifier Type: -

Identifier Source: org_study_id

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