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Correlating Multispectral Near-Infrared Imaging to Standard Vascular Diagnostics

Recruitingn/aAges 18 Years - anyAllMIMOSA Diagnostics Inc.
NCT06899113 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. The main questions it aims to answer are: * Do the MIMOSA Pro tissue oxygenation measures correlate to Ankle-Brachial Index, Toe-Brachial Index, transcutaneous oximetry, and Doppler wave forms? * Do the MIMOSA Pro tissue oxygenation measures correlate with disease classifications for peripheral arterial disease, venous disease, and wound stage? * Is the MIMOSA Pro able to measure vascular status more often than other modalities? Participants will be asked to follow standard of care, and also allow for their legs to imaged by the MIMOSA Pro.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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/will 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. Exclusion Criteria: * 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
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What it tests

  • Not listed
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Where

1 site
Northwell Health Comprehensive Wound Healing Center
Lake Success, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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