Status:
RECRUITING
Correlating Multispectral Near-Infrared Imaging to Standard Vascular Diagnostics
Lead Sponsor:
MIMOSA Diagnostics Inc.
Collaborating Sponsors:
Northwell Health
Conditions:
Vascular Disease, Peripheral
Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer)
Eligibility:
All Genders
18+ years
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 lo...
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...
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
Key Trial Info
Start Date :
May 13 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06899113
Start Date
May 13 2025
End Date
December 1 2025
Last Update
September 11 2025
Active Locations (1)
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1
Northwell Health Comprehensive Wound Healing Center
Lake Success, New York, United States, 11042