Correlating Multispectral Near-Infrared Imaging to Standard Vascular Diagnostics

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.

Study Overview

• Status: Recruiting
• Conditions: Vascular Disease, Peripheral; Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer)

Detailed Description

Observational non-interventional study to assess the use of multispectral near-infrared (MS-NIR) imaging as an adjunct tool in the wound center. No clinical decisions will be made based on information obtained through the use of the MIMOSA device. Objectives are to correlate tissue oxygen saturation (StO2) by MS-NIR to measures by standard vascular diagnostic tools, including ankle-brachial index (ABI), toe-brachial index (TBI), transcutaneous oximetry, Doppler waveforms. Also to assess the ability of MS-NIR to support the classification and grading severity of patients' peripheral artery disease (PAD), venous disease and wound healing and to evaluate the clinical workflow utility of MS-NIR as an adjunct tool in the wound center. The study will recruit patients 18 years old and older, are undergoing an ankle-brachial index exam and recently had/will have further vascular assessment, as per standard of care (inc. transcutaneous oxygen pressure, Doppler waveforms). Participants will be asked to allow for imaging of their lower extremities with the MIMOSA Pro. Investigator will assess participants on their disease and wound status. They will also perform vascular assessments mentioned above as per standard of care. Participants will be followed for 2 months as per regularly scheduled visits. The standard vascular assessment results and disease/wound status will then be correlated with the measures from the MIMOSA Pro.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Alisha Oropallo, MD; Phone Number: 516-233-3780; Email: aoropallo@northwell.edu

Study Locations

• United States
  • New York
    • Lake Success, New York, United States, 11042
      • Recruiting
      • Northwell Health Comprehensive Wound Healing Center
      • Contact: Amit Rao, MD; Phone Number: 516-233-3661; Email: arao3@nothwell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

outpatient wound center

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Correlation coefficient between MIMOSA measures to standard vascular assessment modalities	From baseline to the end of study at 2 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Correlation coefficient between MIMOSA measures to disease and/or wound status	From baseline to the end of study at 2 months

Collaborators and Investigators

• Sponsor: MIMOSA Diagnostics Inc.
• Collaborators: Northwell Health

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 21, 2025
• First Submitted That Met QC Criteria: March 21, 2025
• First Posted (Actual): March 27, 2025

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: September 10, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: TBI; Doppler; peripheral vascular disease; chronic wound; ABI; tissue oxygenation; TcPO2; near-infrared imaging; tissue oximetry; multispectral near-infrared spectroscopy; TCOM
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Skin Diseases; Skin Ulcer; Foot Diseases; Skin and Connective Tissue Diseases; Leg Ulcer; Foot Ulcer; Peripheral Vascular Diseases
• Other Study ID Numbers: MD-OBS-A-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No