[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06899113":3,"trial-entities:NCT06899113":89,"trial-summary:NCT06899113":94},{"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":20,"study_type":32,"primary_purpose":33,"phases":34,"enrollment_info":35,"interventions":38,"primary_outcomes":39,"secondary_outcomes":43,"sex":46,"minimum_age":47,"maximum_age":33,"healthy_volunteers":33,"eligibility_criteria":48,"std_ages":62,"locations":65,"central_contacts":81,"overall_officials":86,"references":87,"see_also_links":88},"NCT06899113","MD-OBS-A-001","Correlating Multispectral Near-Infrared Imaging to Standard Vascular Diagnostics","RECRUITING","2025-12","2025-09","2025-09-11","2025-05-13","MIMOSA Diagnostics Inc.","INDUSTRY",false,"The goal of this observational study is to learn if the measures of tissue oxygenation from the MIMOSA Pro imaging device correlate to standard vascular assessment tools in patients who receiving a lower extremity vascular assessment.\n\nThe main questions it aims to answer are:\n\n* Do the MIMOSA Pro tissue oxygenation measures correlate to Ankle-Brachial Index, Toe-Brachial Index, transcutaneous oximetry, and Doppler wave forms?\n* Do the MIMOSA Pro tissue oxygenation measures correlate with disease classifications for peripheral arterial disease, venous disease, and wound stage?\n* Is the MIMOSA Pro able to measure vascular status more often than other modalities?\n\nParticipants will be asked to follow standard of care, and also allow for their legs to imaged by the MIMOSA Pro.","Observational non-interventional study to assess the use of multispectral near-infrared (MS-NIR) imaging as an adjunct tool in the wound center. No clinical decisions will be made based on information obtained through the use of the MIMOSA device. Objectives are to correlate tissue oxygen saturation (StO2) by MS-NIR to measures by standard vascular diagnostic tools, including ankle-brachial index (ABI), toe-brachial index (TBI), transcutaneous oximetry, Doppler waveforms. Also to assess the ability of MS-NIR to support the classification and grading severity of patients' peripheral artery disease (PAD), venous disease and wound healing and to evaluate the clinical workflow utility of MS-NIR as an adjunct tool in the wound center. The study will recruit patients 18 years old and older, are undergoing an ankle-brachial index exam and recently had\u002Fwill have further vascular assessment, as per standard of care (inc. transcutaneous oxygen pressure, Doppler waveforms). Participants will be asked to allow for imaging of their lower extremities with the MIMOSA Pro. Investigator will assess participants on their disease and wound status. They will also perform vascular assessments mentioned above as per standard of care. Participants will be followed for 2 months as per regularly scheduled visits. The standard vascular assessment results and disease\u002Fwound status will then be correlated with the measures from the MIMOSA Pro.",[18,19],"Vascular Disease, Peripheral","Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer)",[21,22,23,24,25,26,27,28,29,30,31],"multispectral near-infrared spectroscopy","chronic wound","peripheral vascular disease","near-infrared imaging","ABI","tissue oxygenation","tissue oximetry","TBI","TCOM","TcPO2","Doppler","OBSERVATIONAL",null,[],{"count":36,"type":37},60,"ESTIMATED",[],[40],{"measure":41,"timeFrame":42},"Correlation coefficient between MIMOSA measures to standard vascular assessment modalities","From baseline to the end of study at 2 months",[44],{"measure":45,"timeFrame":42},"Correlation coefficient between MIMOSA measures to disease and\u002For wound status","ALL","18 Years",{"inclusion":49,"exclusion":56,"raw_text":61},[50,51,52,53,54,55],"Provision of signed and dated informed consent form","Stated willingness to comply with all study procedures and availability for the duration of the study","Male or female, aged 18 and older","Patient is undergoing an ABI test.","Patient recently had\u002Fwill have further vascular assessment, as per standard of care (inc. transcutaneous oxygen pressure, Doppler waveforms)","Patients who can be followed by the same investigating team for the whole period of their participation in the study.",[57,58,59,60],"Patients who are participating in another clinical study for ulcer management","Patients who are unable to understand the aims of the study and not able to provide informed consent","Receiving radiation to the extremity","Active charcot joints","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or female, aged 18 and older\n* Patient is undergoing an ABI test.\n* Patient recently had\u002Fwill have further vascular assessment, as per standard of care (inc. transcutaneous oxygen pressure, Doppler waveforms)\n* Patients who can be followed by the same investigating team for the whole period of their participation in the study.\n\nExclusion Criteria:\n\n* Patients who are participating in another clinical study for ulcer management\n* Patients who are unable to understand the aims of the study and not able to provide informed consent\n* Receiving radiation to the extremity\n* Active charcot joints",[63,64],"ADULT","OLDER_ADULT",[66],{"facility":67,"status":7,"city":68,"state":69,"zip":70,"country":71,"contacts":72,"geoPoint":78},"Northwell Health Comprehensive Wound Healing Center","Lake Success","New York","11042","United States",[73],{"name":74,"role":75,"phone":76,"email":77},"Amit Rao, MD","CONTACT","516-233-3661","arao3@nothwell.edu",{"lat":79,"lon":80},40.77066,-73.71763,[82],{"name":83,"role":75,"phone":84,"email":85},"Alisha Oropallo, MD","516-233-3780","aoropallo@northwell.edu",[],[],[],{"nct_id":4,"conditions":90,"biomarkers":93},[91,92],"Chronic wound","Peripheral Vascular Disorder",[],{"nct_id":4,"found":95,"summary":96,"prompt_version":106},true,{"design":97,"status":98,"heading":99,"summary":100,"follow_up":101,"word_count":102,"commitments":103,"compensation":104,"drugs_mentioned":105},"This is an observational study, meaning you will follow your usual care while researchers gather information. It aims to enroll 60 participants.","completed","Observational Study: MIMOSA Pro Imaging for Vascular Disease","This observational study is looking at how well a new imaging device, the MIMOSA Pro, measures oxygen levels in your leg tissues compared to standard tests for vascular disease (problems with blood vessels). If you have vascular disease or a chronic wound on your leg, like a leg or foot ulcer, and are having an Ankle-Brachial Index (ABI) test and other vascular assessments, you might be able to join. The researchers want to see if the MIMOSA Pro's measurements match up with results from tests like ABI, Toe-Brachial Index (TBI), and transcutaneous oximetry. They also want to see if it can help classify your disease and wound stage, and if it's easy to use in a clinic. This study is currently unclear on its recruitment status and plans to enroll 60 participants.","Participants will be followed for 2 months as per regularly scheduled visits.",132,"You will allow your legs to be imaged by the MIMOSA Pro device. You will be followed for 2 months during your regularly scheduled visits.","Not stated in the trial record.",[],"v2"]