Non-Invasive Testing to Evaluate Wound Healing in Diabetes
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
| Condition(s) | Diabetic Foot Ulcer |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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, hemoglo |
| Who can participate | 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 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 st |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | University of Texas Southwestern Medical Center |
| Locations | Dallas, Texas, United States |
| Start date | 2021-04-28 |
| NCT ID | NCT04232631 |
| Official listing | https://clinicaltrials.gov/study/NCT04232631 |