Peripheral Arterial DiseaseTICNCT06544135
Use of Thermal Imaging Camera to Assess Perfusion Before and After Vascular Intervention
An observational study of Peripheral Arterial Disease and Critical Limb Ischemia, run by University Hospitals Cleveland Medical Center at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Peripheral Arterial Disease, Critical Limb Ischemia, Critical Lower Limb Ischemia
- What is being tested?
- FLIR One Pro LT
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Apr 2025to Oct 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People between ages 18 and 99 years with lower extremity peripheral artery disease with a planned endovascular intervention.
Who may be able to join
- Lower extremity peripheral artery disease with tissue loss consistent with Rutherford classification V or VI.
- Planned lower extremity endovascular intervention
Who cannot join
- Non-arterial ulcers
- Pregnant
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
University Hospitals Ahuja Medical Center
Beachwood, Ohio, 44122
Jun Li, MD
Tarek Hammad, MD
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Jun Li, MD, 440-882-0075, Jun.Li@UHhospitals.org
Mehdi H Shishehbor, DO
- Recruiting
University Hospitals Parma Medical Center
Parma, Ohio, 44129
Jun Li, MD
Yulanka Castro, MD
About this study
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?
Read the 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.
- Being tested
- FLIR One Pro LT
- Medical subject headings
- Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLIR One Pro LTDevice
Thermal imaging camera used to measure temperatures of the lower limb.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: FLIR One Pro LT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ABI
Ankle brachial index will be taken before and after intervention and correlated with thermal readings from FLIR.
Measured: Up to 90 days before revascularization; Up to 1 year after revascularization
Secondary outcomes (3)
Major amputations
Any associated amputations the subject had after revascularization
Measured: Up to 1 year after revascularization
Major revascularizations post-initial intervention
Any revascularization procedures done after the initial revascularization
Measured: Up to 1 year after revascularization
Mortality
Subject deaths during the length of the study
Measured: Up to 1 year after revascularization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start14 Apr 2025
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Li, MD, Principal investigator, University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06544135
- Sponsor's protocol ID
- STUDY20230726
- Acronym
- TIC
- Status last verified
- Jul 2026
- First submitted
- 8 May 2024
- Last updated
- 2 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Thermal Imaging Camera to Assess Perfusion Before and After Vascular Intervention
- ClinicalTrials.gov ID
- NCT06544135
- Acronym / sponsor ID
- TIC / STUDY20230726
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FLIR thermal imaging group | – | Device: FLIR One Pro LTTemperature measurements will be taken of the lower limb using the FLIR camera and correlated with other aspects of each patient. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People between ages 18 and 99 years with lower extremity peripheral artery disease with a planned endovascular intervention.
Key inclusion criteria (2 listed)
- Lower extremity peripheral artery disease with tissue loss consistent with Rutherford classification V or VI.
- Planned lower extremity endovascular intervention
Key exclusion criteria (2 listed)
- Non-arterial ulcers
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FLIR One Pro LTThermal imaging camera used to measure temperatures of the lower limb. | Device | FLIR thermal imaging group |
Primary outcome
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.
3 secondary outcomes
Major amputations
Time frame: Up to 1 year after revascularization
Major revascularizations post-initial intervention
Time frame: Up to 1 year after revascularization
Mortality
Time frame: Up to 1 year after revascularization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jun Li, MD principal investigator
University Hospitals
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease and Critical Limb Ischemia, run by University Hospitals Cleveland Medical Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Li, MD ((734) 968-5212, jun.li@uhhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ABI (time frame: Up to 90 days before revascularization; Up to 1 year after revascularization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.