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Correlating Multispectral Near-Infrared Imaging to Standard Vascular Diagnostics

NCT06899113 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2025-09-11

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Northwell Health

    collaborator OTHER

  • MIMOSA Diagnostics Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-13
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06899113 on ClinicalTrials.gov