Correlating Multispectral Near-Infrared Imaging to Standard Vascular Diagnostics

Part of paid clinical trials in Lake Success, New York.

Sponsor
MIMOSA Diagnostics Inc.
Study ID
NCT06899113
Status
Recruiting
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Conditions

  • Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer)
  • Vascular Disease, Peripheral

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
May 13, 2025
Status verified
Sep 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
60 participants (estimated)

Primary Outcome Measure

Correlation coefficient between MIMOSA measures to standard vascular assessment modalities [ Time Frame: From baseline to the end of study at 2 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwell Health Comprehensive Wound Healing CenterLake SuccessNew York11042
Amit Rao, MD
[email protected]
516-233-3661

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By research site
Northwell Health Comprehensive Wound Healing Center· Lake Success, NY

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