25 Participants Needed

Thermal Imaging for Peripheral Artery Disease

(TIC Trial)

Recruiting at 2 trial locations
GC
JL
Overseen ByJun Li, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Jun Li
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special thermal camera can predict improvements in blood flow in the legs after a procedure to open blocked arteries. Researchers will measure temperature changes in the lower limbs before and after the procedure using the camera. The goal is to determine if these temperature readings can indicate the treatment's success. The study seeks participants with severe peripheral artery disease in their legs who are scheduled for a procedure to improve blood flow. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the FLIR One Pro LT is safe for use in measuring lower extremity temperature?

Studies have shown that the FLIR One Pro LT is commonly used for inspecting electrical panels and heating and cooling systems. This device transforms a smartphone into a camera that detects heat, helping to identify problems by highlighting temperature variations.

Regarding safety, the FLIR One Pro LT does not make contact with the body. It captures heat images, making it non-invasive. No reports indicate it causes harm, as it is solely used for measuring temperature, not treatment.

In this study, researchers are using the FLIR camera to determine if it can help predict the outcomes of a medical procedure. The camera is safe and does not physically affect the body.12345

Why are researchers excited about this trial?

Researchers are excited about using thermal imaging cameras to assess blood flow in the legs before and after vascular procedures because this method offers a non-invasive, quick, and detailed way to evaluate circulation. Unlike traditional techniques that may require more invasive procedures or rely on less direct indicators of blood flow, thermal imaging provides real-time visual data by detecting heat patterns. This innovative approach could lead to faster and more accurate assessments, helping doctors make better decisions on patient care and potentially improving outcomes for those with vascular issues.

What evidence suggests that FLIR thermal imaging is effective for predicting revascularization outcomes?

Research has shown that thermal imaging is useful in healthcare. One study found that thermal cameras can predict limb healing after amputation with 80 to 90% accuracy by checking skin temperature. Another study discovered that the FLIR T560 camera quickly measures skin temperature, aiding in the detection of nerve problems. In this trial, researchers will use the FLIR camera to take temperature measurements of participants' lower limbs. These findings suggest that checking leg temperatures with a FLIR camera might help predict the success of procedures aimed at improving blood flow.678910

Who Is on the Research Team?

JL

Jun Li, MD

Principal Investigator

University Hospitals

Are You a Good Fit for This Trial?

Inclusion Criteria

I have severe leg artery disease with tissue loss.
I am scheduled for a procedure on the arteries in my legs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Pre-intervention

Initial visit for consent and baseline thermal imaging of lower extremity

1 week
1 visit (in-person)

Intervention

Scheduled revascularization procedure with immediate post-intervention thermal imaging

1 day
1 visit (in-person)

Follow-up

Weekly follow-up visits for thermal imaging post-intervention for at least 1 month, up to 6 months

4-24 weeks
4-24 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • FLIR One Pro LT

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: FLIR thermal imaging groupExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jun Li

Lead Sponsor

Trials
11
Recruited
2,300+

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials
348
Recruited
394,000+

Citations

A CARE-compliant case report - PMC - PubMed Central

Here, we investigated the effectiveness of the FLIR T560 thermal imaging camera in detecting hypothermic changes associated with radiculopathy caused by spinal ...

Thermographic Patterns of the Upper and Lower Limbs

Objective measurement of skin temperature has been shown to predict amputation healing with an accuracy of 80 to 90% [10]. Beyond these areas however the use of ...

Influence of infrared camera resolution and operator ...

This study evaluates the reproducibility of three FLIR thermal cameras with different resolutions (A655SC, E60, One Pro) and the influence of ...

Thermal imaging responses of lower-limb muscles following ...

This study aimed to evaluate the acute changes in lower extremity muscle thermal skin temperature(Tsk) in amateur male soccer players following the Wingate ...

Usefulness of digital infrared thermography video using the ...

The FLIR T560 enables real-time measurement of skin temperature in a clinical setting, allowing for the rapid identification of nerve ...

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