Clinical Trial

Correlating Multispectral Near-Infrared Imaging to Standard Vascular Diagnostics

Recruiting
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Record status
This record was last updated September 11, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-03-21.
Status change: Not Yet Recruiting → Recruiting 2025-09-10
Trial Details
NCT Number NCT06899113
Lead Sponsor MIMOSA Diagnostics Inc.
Collaborators: Northwell Health
Conditions Vascular Disease, Peripheral, Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer)
Enrollment 60 participants
Start Date 2025-05-13
Primary Completion 2025-12 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2025-09-11