Recruiting

Observational Study

Sponsor:

MIMOSA Diagnostics Inc.

Code:

NCT06899113

Conditions

Vascular Disease, Peripheral

Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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)

Study ID

NCT06899113

Start date

May 13, 2025

Status verified date

Sep, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Correlation coefficient between MIMOSA measures to standard vascular assessment modalities [ Time Frame: From baseline to the end of study at 2 months ]

Central Contacts and Locations

Central contacts

Alisha Oropallo, MD

516-233-3780aoropallo@northwell.edu

Locations

Northwell Health Comprehensive Wound Healing Center

Recruiting

Lake Success, New York, United States, 11042

Contacts

Amit Rao, MD

516-233-3661arao3@nothwell.edu

More Information

Sponsor

MIMOSA Diagnostics Inc.

Last update posted

Sep 11, 2025

Last verified

Sep, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by MIMOSA Diagnostics Inc. on 2025-09-11.