Non-Invasive Testing to Evaluate Wound Healing in Diabetes
University of Texas Southwestern Medical Center
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.
Description
This is a prospective, observational study. All medical and surgical care provided to the patient group will be standard of care. Patient group: Once a patient is identified as requiring vascular intervention or lower extremity ulceration (includes lower extremity wound of any cause, a surgical incision, a flap or graft) and consent to participation, their lower extremity will be imaged. They will be imaged preop, intraop (if feasible) and on post-op day 1 + or - 7 days if they require surgery and for each surgery related to the ulceration. They will also be imaged once a month in follow up f…
Eligibility
- Age range
- 18–89 years
- Sex
- All
- Healthy volunteers
- Yes
Investigator patients Inclusion Criteria: * Patient of the investigators * Diagnosis of diabetes mellitus * One or more moderate to severe diabetic foot ulcers/infections * 18-89 years of age Exclusion Criteria: * 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 psychiatri…
Interventions
- DeviceSnapshotNIR, Kent Imaging
Vascular imaging device
Location
- UT Southwestern Medical Center at DallasDallas, Texas