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Clinical Trials in the USA / NCT06899113
Recruiting Observational

Correlating Multispectral Near-Infrared Imaging to Standard Vascular Diagnostics

NCT06899113 · tracked via the Priya Life Science USA tracker
Sponsor
MIMOSA Diagnostics Inc
Phase
Observational
Started
2025-05-13
Last updated
2025-09-11

Condition(s) studied

Vascular Disease, PeripheralChronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer)

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Correlation coefficient between MIMOSA measures to standard vascular assessment modalities — From baseline to the end of study at 2 months

Trial sites (1)

FacilityCityRegionStatus
Northwell Health Comprehensive Wound Healing Center Lake Success New York Recruiting

Other trials for the same condition

Miro3D Wound Matrix Study for Diabetic Foot Ulcers and Wound Healing Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06899113 on ClinicalTrials.gov ↗ ← All trials in the USA