Correlating Multispectral Near-Infrared Imaging to Standard Vascular Diagnostics
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMIMOSA Diagnostics Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
outpatient wound center
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Correlation coefficient between MIMOSA measures to standard vascular assessment modalities
Time frame
From baseline to the end of study at 2 monthsSecondary outcomes
1
Correlation coefficient between MIMOSA measures to disease and/or wound status
Time frame
From baseline to the end of study at 2 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
MIMOSA Diagnostics Inc.
Lead sponsor
Northwell Health
Collaborator
Source ClinicalTrials.gov