RecruitingNCT04232631

Non-Invasive Testing to Evaluate Wound Healing in Diabetes


Sponsor

University of Texas Southwestern Medical Center

Enrollment

700 participants

Start Date

Apr 28, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

Normal group: We will collect normative data from healthy individuals to include baseline data, screening, and images. Up to 500 people will be enrolled and can include normal healthy volunteers, staff and students/trainees. Data will be collected one time with no follow up. Patient group: We will prospectively collect data using one instrument (camera) (SnapshotNIR, Kent Imaging, Calgary, Alberta, Canada). We will collect non-contact imaging data before surgeries, during surgeries (if feasible), and during follow-up clinic visits. We will collect vascular data, demographic medical history, wound characteristics and measurements, frequency of debridement, off-loading, and clinic visits from existing medical records. We will collect lab data such as cultures glycosylated hemoglobin, hemoglobin and hematocrit, ESR, CRP and eGFR obtained per standard of care. Imaging with this device is research-only.


Eligibility

Min Age: 18 YearsMax Age: 89 Years

Inclusion Criteria7

  • Investigator patients
  • Patient of the investigators
  • Diagnosis of diabetes mellitus
  • One or more moderate to severe diabetic foot ulcers/infections
  • -89 years of age
  • Over 18
  • Have a foot

Exclusion Criteria9

  • Non-diabetic
  • Is pregnant or plans to become pregnant
  • Is nursing or actively lactating
  • Developmental disability/significant psychological disorder that in the opinion of the investigator could impair the subject's ability to provide informed consent, participate in the study protocol or record study measures, including untreated schizophrenia, bipolar disorder and psychiatric hospitalization within the last 2 years.
  • Active alcohol or substance abuse in the opinion of the investigator that could impair the subject's ability to provide informed consent, participate in the study protocol or record study materials
  • Patients with a history of poor compliance
  • Normal Healthy volunteers
  • Foot wounds
  • Non-English speaking

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICESnapshotNIR, Kent Imaging

Vascular imaging device


Locations(1)

UT Southwestern Medical Center at Dallas

Dallas, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04232631


Related Trials