RECRUITINGOBSERVATIONAL

Non-Invasive Testing to Evaluate Wound Healing in Diabetes

About This Trial

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.

Who May Be Eligible (Plain English)

Investigator patients Who May Qualify: - Patient of the investigators - Diagnosis of diabetes mellitus - One or more moderate to severe diabetic foot ulcers/infections - 18-89 years of age Who Should NOT Join This Trial: - 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 willing to sign a consent form, 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 willing to sign a consent form, participate in the study protocol or record study materials - Patients with a history of poor compliance Normal Healthy volunteers Who May Qualify: - Over 18 - Have a foot Who Should NOT Join This Trial: - Foot wounds - Non-English speaking Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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 study protocol or record study materials * Patients with a history of poor compliance Normal Healthy volunteers Inclusion Criteria: * Over 18 * Have a foot Exclusion Criteria: * Foot wounds * Non-English speaking

Treatments Being Tested

DEVICE

SnapshotNIR, Kent Imaging

Vascular imaging device

Locations (1)

UT Southwestern Medical Center at Dallas

Dallas, Texas, United States