University of Texas Southwestern Medical Center
Peter Crisolog, DPM
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.
Diabetic Foot Ulcer
SnapshotNIR, Kent Imaging
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 for up to a total of 6 months or healing of the wound, determined by study physician. Normal group: The normal group will have one-time imaging and data collection. The Kent instrument does not touch the patient and is being evaluated to measure perfusion to predict wound healing, flap survival and amputation level healing. They are research only and not standard of care, and are not being used to determine care in the patient group.
| Study Type : | OBSERVATIONAL |
| Estimated Enrollment : | 700 participants |
| Official Title : | Non-Invasive Testing to Evaluate Wound Healing in Diabetes |
| Actual Study Start Date : | 2021-04-28 |
| Estimated Primary Completion Date : | 2026-09 |
| Estimated Study Completion Date : | 2026-09 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years to 89 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: | 1 |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390