Use of Thermal Imaging Camera to Assess Perfusion Before and After Vascular Intervention
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorUniversity Hospitals Cleveland Medical Center
About this trial
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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Lower extremity peripheral artery disease with tissue loss consistent with Rutherford classification V or VI.
Planned lower extremity endovascular intervention
Disqualifiers
Non-arterial ulcers
Pregnant
Trial population
People between ages 18 and 99 years with lower extremity peripheral artery disease with a planned endovascular intervention.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
FLIR One Pro LT
DeviceThermal imaging camera used to measure temperatures of the lower limb.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: FLIR thermal imaging group1 intervention
Trial outcomes
Primary outcomes
1
Change in ABI
Ankle brachial index will be taken before and after intervention and correlated with thermal readings from FLIR.
Time frame
Up to 90 days before revascularization; Up to 1 year after revascularizationSecondary outcomes
1
Major amputations
Any associated amputations the subject had after revascularization
Time frame
Up to 1 year after revascularization2
Major revascularizations post-initial intervention
Any revascularization procedures done after the initial revascularization
Time frame
Up to 1 year after revascularization3
Mortality
Subject deaths during the length of the study
Time frame
Up to 1 year after revascularizationSponsors and contacts
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Source ClinicalTrials.gov