Correlating Multispectral Near-Infrared Imaging to Standard Vascular Diagnostics

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
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• 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.

Locations
United States
New York
Northwell Health Comprehensive Wound Healing Center
RECRUITING
Lake Success
Contact Information
Primary
Alisha Oropallo, MD
aoropallo@northwell.edu
516-233-3780
Time Frame
Start Date: 2025-05-13
Estimated Completion Date: 2025-12
Participants
Target number of participants: 60
Sponsors
Collaborators: Northwell Health
Leads: MIMOSA Diagnostics Inc.

This content was sourced from clinicaltrials.gov