Correlating Multispectral Near-Infrared Imaging to Standard Vascular Diagnostics

NCT06899113 | Recruiting

• 1 other identifier: MD-OBS-A-001
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

multispectral near-infrared spectroscopy; chronic wound; peripheral vascular disease; near-infrared imaging; ABI; tissue oxygenation; tissue oximetry; TBI; TCOM; TcPO2; Doppler

Outcome Measures

Primary Outcomes (1)

• Correlation coefficient between MIMOSA measures to standard vascular assessment modalities

  From baseline to the end of study at 2 months

Secondary Outcomes (1)

• Correlation coefficient between MIMOSA measures to disease and/or wound status

  From baseline to the end of study at 2 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

outpatient wound center

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• MIMOSA Diagnostics Inc.: lead
• Northwell Health: collaborator

Study Sites (1)

Northwell Health Comprehensive Wound Healing Center

Lake Success, New York, 11042, United States

RECRUITING

MeSH Terms

Conditions

Peripheral Vascular Diseases; Leg Ulcer; Foot Ulcer

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Foot Diseases

Central Study Contacts

Alisha Oropallo, MD

CONTACT

516-233-3780; aoropallo@northwell.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: March 27, 2025
• Study Start: May 13, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)