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Observational Study: MIMOSA Pro Imaging for Vascular Disease

This observational study is looking at how well a new imaging device, the MIMOSA Pro, measures oxygen levels in your leg tissues compared to standard tests for vascular disease (problems with blood vessels). If you have vascular disease or a chronic wound on your leg, like a leg or foot ulcer, and are having an Ankle-Brachial Index (ABI) test and other vascular assessments, you might be able to join. The researchers want to see if the MIMOSA Pro's measurements match up with results from tests like ABI, Toe-Brachial Index (TBI), and transcutaneous oximetry. They also want to see if it can help classify your disease and wound stage, and if it's easy to use in a clinic. This study is currently unclear on its recruitment status and plans to enroll 60 participants.

Study design
This is an observational study, meaning you will follow your usual care while researchers gather information. It aims to enroll 60 participants.
What's involved
You will allow your legs to be imaged by the MIMOSA Pro device. You will be followed for 2 months during your regularly scheduled visits.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 2 months as per regularly scheduled visits.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06899113

Correlating Multispectral Near-Infrared Imaging to Standard Vascular Diagnostics

Recruiting
Not specifiedAges 18+Observational
MIMOSA Diagnostics Inc.
~60 participants
Updated 2025-09-11 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Correlation coefficient between MIMOSA measures to standard vascular assessment modalities
Measured over From baseline to the end of study at 2 months

Conditions

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

Explore related trials

Chronic woundPeripheral Vascular Disorder

Where it's being run

1 sites across 1 states
New York1

Who to contact

Alisha Oropallo, MD
[email protected]
516-233-3780
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

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