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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?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FLIR thermal imaging group | Temperature measurements will be taken of the lower limb using the FLIR camera and correlated with other aspects of each patient. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FLIR One Pro LT | Device | Thermal imaging camera used to measure temperatures of the lower limb. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in ABI | Ankle brachial index will be taken before and after intervention and correlated with thermal readings from FLIR. | Up to 90 days before revascularization; Up to 1 year after revascularization |
| Measure | Description | Time Frame |
|---|---|---|
| Major amputations | Any associated amputations the subject had after revascularization | Up to 1 year after revascularization |
| Major revascularizations post-initial intervention | Any revascularization procedures done after the initial revascularization |
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Inclusion Criteria:
Exclusion Criteria:
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People between ages 18 and 99 years with lower extremity peripheral artery disease with a planned endovascular intervention.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Li, MD | Contact | (734) 968-5212 | jun.li@uhhospitals.org | |
| Grace Craig, DPM | Contact | 408 628 8102 | gracecraigdpm@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jun Li, MD | University Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Ahuja Medical Center | Recruiting | Beachwood | Ohio | 44122 | United States |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D000089802 | Chronic Limb-Threatening Ischemia |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| Up to 1 year after revascularization |
| Mortality | Subject deaths during the length of the study | Up to 1 year after revascularization |
| University Hospitals Cleveland Medical Center | Recruiting | Cleveland | Ohio | 44106 | United States |
|
| University Hospitals Parma Medical Center | Recruiting | Parma | Ohio | 44129 | United States |
|
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |