MIMOSA Pro near-infrared tissue oxygen imaging compared with standard leg vascular tests
Official title: Correlating Multispectral Near-Infrared Imaging to Standard Vascular Diagnostics
Run by MIMOSA Diagnostics Inc. · NCT06899113 · Data updated 2026-11-12
This project tries to see if the MIMOSA Pro near‑infrared camera can measure leg tissue oxygen as well as standard vascular tests in adults having lower‑limb vascular assessments.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | MIMOSA Diagnostics Inc. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Lake Success, New York) |
| Status | Recruiting |
| Started | May 13, 2025 |
| Main results expected | December 2025 |
| Study ends | December 2025 |
| Registry record updated | September 11, 2025 |
| Trial ID | NCT06899113 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) who are undergoing an ABI and additional vascular testing for peripheral vascular disease or lower‑limb wounds, can give informed consent, and can be followed by the same clinical team for the study period.
✕Probably not a fit
Patients receiving radiation to the limb, those with active Charcot joints, individuals unable to provide informed consent, or people already enrolled in another ulcer management trial may not benefit from or be eligible for this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational, non‑interventional study at a Northwell Health wound center will image adults undergoing ankle‑brachial index (ABI) and related vascular tests using the MIMOSA Pro multispectral near‑infrared device. Investigators will record tissue oxygen saturation (StO2) from MS‑NIR imaging and compare those measures to ABI, toe‑brachial index (TBI), transcutaneous oxygen (TcPO2), and Doppler waveforms, as well as to PAD/venous disease and wound stage classifications. No clinical decisions will be made based on MIMOSA results and participants will follow standard care; imaging is performed as an adjunct and participants will be followed for about two months during routine visits. The analysis will focus on correlation between modalities and how often MS‑NIR provides usable vascular information compared with standard tools.
Why it matters
Potential benefit: If successful, MIMOSA Pro imaging could provide a fast, non‑contact way to identify tissue oxygen deficits and support vascular and wound assessments in clinic.
How similar studies have gone: Prior small studies of near‑infrared spectroscopy or imaging have shown promising correlations with tissue oxygenation, but larger clinical validation in wound care settings remains limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Northwell Health Comprehensive Wound Healing Center
Lake Success, New York, United States Recruiting
Study contacts
- Study coordinator: Alisha Oropallo, MD
- Email: aoropallo@northwell.edu
- Phone: 516-233-3780
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.