Clinical trial NCT06544135: Use of Thermal Imaging Camera to Assess Perfusion Before and After Vascular Intervention
Official title: Use of Thermal Imaging Camera to Assess Perfusion Before and After Vascular Intervention
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peripheral Arterial Disease
Critical Limb Ischemia
Critical Lower Limb Ischemia
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in ABI
timeFrame: Up to 90 days before revascularization; Up to 1 year after revascularization
Secondary outcomes:
measure: Major amputations
timeFrame: Up to 1 year after revascularization
measure: Major revascularizations post-initial intervention
timeFrame: Up to 1 year after revascularization
measure: Mortality
timeFrame: Up to 1 year after revascularization
Other outcomes:
Locations:
city: Beachwood
country: United States
facility: University Hospitals Ahuja Medical Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Parma
country: United States
facility: University Hospitals Parma Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals
name: Jun Li, MD
role: PRINCIPAL_INVESTIGATOR
References: