Use of Thermal Imaging Camera to Assess Perfusion Before and After Vascular Intervention
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 25
- Locations
- 4
- Primary Endpoint
- Change in ABI
Study 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)