[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06544135":3,"trial-entities:NCT06544135":120,"trial-summary:NCT06544135":125},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":22,"primary_purpose":14,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":34,"secondary_outcomes":39,"sex":50,"minimum_age":51,"maximum_age":52,"healthy_volunteers":53,"eligibility_criteria":54,"std_ages":62,"locations":65,"central_contacts":106,"overall_officials":114,"references":118,"see_also_links":119},"NCT06544135","STUDY20230726","Use of Thermal Imaging Camera to Assess Perfusion Before and After Vascular Intervention","RECRUITING","2027-10","2026-07","2026-07-02","2025-04-14","University Hospitals Cleveland Medical Center","OTHER",null,"This is a preliminary prospective observational study measuring change in lower extremity temperature in response to revascularization procedure.\n\nThe main question this study aims to answer is:\n\n\\- 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.\n\nPatients 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.\n\nData will be gathered at a consistent location to minimize impact of room temperature on measurements.\n\nPatients will then undergo scheduled revascularization with the interventionist.\n\nPost-intervention pictures will be taken immediately after revascularization.\n\nPatients 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.\n\nThermal measurements will be correlated with intra-op imaging and clinical outcomes in data analysis.",[18,19,20],"Peripheral Arterial Disease","Critical Limb Ischemia","Critical Lower Limb Ischemia",[],"OBSERVATIONAL",[],{"count":25,"type":26},25,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DEVICE","FLIR One Pro LT","Thermal imaging camera used to measure temperatures of the lower limb.",[33],"FLIR thermal imaging group",[35],{"measure":36,"description":37,"timeFrame":38},"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",[40,44,47],{"measure":41,"description":42,"timeFrame":43},"Major amputations","Any associated amputations the subject had after revascularization","Up to 1 year after revascularization",{"measure":45,"description":46,"timeFrame":43},"Major revascularizations post-initial intervention","Any revascularization procedures done after the initial revascularization",{"measure":48,"description":49,"timeFrame":43},"Mortality","Subject deaths during the length of the study","ALL","18 Years","99 Years",false,{"inclusion":55,"exclusion":58,"raw_text":61},[56,57],"Lower extremity peripheral artery disease with tissue loss consistent with Rutherford classification V or VI.","Planned lower extremity endovascular intervention",[59,60],"Non-arterial ulcers","Pregnant","Inclusion Criteria:\n\n* Lower extremity peripheral artery disease with tissue loss consistent with Rutherford classification V or VI.\n* Planned lower extremity endovascular intervention\n\nExclusion Criteria:\n\n* Non-arterial ulcers\n* Pregnant",[63,64],"ADULT","OLDER_ADULT",[66,82,95],{"facility":67,"status":7,"city":68,"state":69,"zip":70,"country":71,"contacts":72,"geoPoint":79},"University Hospitals Ahuja Medical Center","Beachwood","Ohio","44122","United States",[73,76],{"name":74,"role":75},"Jun Li, MD","CONTACT",{"name":77,"role":78},"Tarek Hammad, MD","SUB_INVESTIGATOR",{"lat":80,"lon":81},41.4645,-81.50873,{"facility":12,"status":7,"city":83,"state":69,"zip":84,"country":71,"contacts":85,"geoPoint":92},"Cleveland","44106",[86,89,91],{"name":74,"role":75,"phone":87,"email":88},"440-882-0075","Jun.Li@UHhospitals.org",{"name":90,"role":78},"Mehdi H Shishehbor, DO",{"name":77,"role":78},{"lat":93,"lon":94},41.4995,-81.69541,{"facility":96,"status":7,"city":97,"state":69,"zip":98,"country":71,"contacts":99,"geoPoint":103},"University Hospitals Parma Medical Center","Parma","44129",[100,101],{"name":74,"role":75},{"name":102,"role":78},"Yulanka Castro, MD",{"lat":104,"lon":105},41.40477,-81.72291,[107,110],{"name":74,"role":75,"phone":108,"email":109},"(734) 968-5212","jun.li@uhhospitals.org",{"name":111,"role":75,"phone":112,"email":113},"Grace Craig, DPM","408 628 8102","gracecraigdpm@gmail.com",[115],{"name":74,"affiliation":116,"role":117},"University Hospitals","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":121,"biomarkers":124},[122,123],"Chronic Limb-Threatening Ischemia","Peripheral Artery Disease",[],{"nct_id":4,"found":126,"summary":127,"prompt_version":137},true,{"design":128,"status":129,"heading":130,"summary":131,"follow_up":132,"word_count":133,"commitments":134,"compensation":135,"drugs_mentioned":136},"This is an observational study, meaning researchers will watch and collect information without giving you a specific treatment. It plans to include 25 participants.","completed","Observational Study: Thermal Imaging for Peripheral Arterial Disease","This study is looking at whether a special camera, called the FLIR One Pro LT, can help doctors understand how well a procedure to improve blood flow in your leg works. This camera measures the temperature of your lower leg before and after you have a revascularization procedure (a procedure to restore blood flow). The study will follow 25 people who have severe peripheral arterial disease (PAD), which means they have poor blood flow to their legs and feet, causing tissue damage. You might be able to join if you are 18 to 99 years old, have severe PAD with tissue loss, and are planning to have a revascularization procedure in your leg. The main goal is to see if changes in leg temperature, measured by the camera, can predict how successful the revascularization procedure will be.","You will be followed for up to one year after your revascularization procedure to measure changes in your ABI (Ankle-Brachial Index), which is a measure of blood flow.",137,"You would have thermal camera measurements taken before your procedure, immediately after, and then weekly for at least one month, up to six months. Your medical records will also be reviewed.","Not stated in the trial record.",[30],"v2"]