RECRUITING

Correlating Multispectral Near-Infrared Imaging to Standard Vascular Diagnostics

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Correlating Multispectral Near-Infrared Imaging to Standard Vascular Diagnostics

Quick Facts

Study Start:2025-05-13
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06899113

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provision of signed and dated informed consent form
  2. * Stated willingness to comply with all study procedures and availability for the duration of the study
  3. * Male or female, aged 18 and older
  4. * Patient is undergoing an ABI test.
  5. * Patient recently had/will have further vascular assessment, as per standard of care (inc. transcutaneous oxygen pressure, Doppler waveforms)
  6. * Patients who can be followed by the same investigating team for the whole period of their participation in the study.
  1. * Patients who are participating in another clinical study for ulcer management
  2. * Patients who are unable to understand the aims of the study and not able to provide informed consent
  3. * Receiving radiation to the extremity
  4. * Active charcot joints

Contacts and Locations

Study Contact

Alisha Oropallo, MD
CONTACT
516-233-3780
aoropallo@northwell.edu

Study Locations (Sites)

Northwell Health Comprehensive Wound Healing Center
Lake Success, New York, 11042
United States

Collaborators and Investigators

Sponsor: MIMOSA Diagnostics Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-13
Study Completion Date2025-12

Study Record Updates

Study Start Date2025-05-13
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Vascular Disease, Peripheral
  • Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer)