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Clinical Trials/NCT06544135
NCT06544135
Recruiting
Not Applicable

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

University Hospitals Cleveland Medical Center3 sites in 1 country25 target enrollmentApril 14, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peripheral Arterial Disease
Sponsor
University Hospitals Cleveland Medical Center
Enrollment
25
Locations
3
Primary Endpoint
Change in ABI
Status
Recruiting
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 14, 2025
End Date
October 2027
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

  • Mortality(Up to 1 year after revascularization)
  • Major amputations(Up to 1 year after revascularization)
  • Major revascularizations post-initial intervention(Up to 1 year after revascularization)

Study Sites (3)

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