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NCT Number: NCT06544135

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

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?

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals Ahuja Medical Center, Beachwood, Ohio, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FLIR One Pro LT

Device

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

Primary outcomes

  1. Change in ABI

    Time frame: 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 outcomes

  1. Major amputations

    Time frame: Up to 1 year after revascularization

    Any associated amputations the subject had after revascularization

  2. Major revascularizations post-initial intervention

    Time frame: Up to 1 year after revascularization

    Any revascularization procedures done after the initial revascularization

  3. Mortality

    Time frame: Up to 1 year after revascularization

    Subject deaths during the length of the study

Study contacts

Contact information is provided by the study sponsor or research team.

Grace Craig, DPM

CONTACT

[email protected]

408 628 8102

Jun Li, MD

CONTACT

[email protected]

(734) 968-5212

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Registry information

Acronym: TIC

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 9, 2024
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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