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Suspended
NCT04232631
Non-Invasive Testing to Evaluate Wound Healing in Diabetes
Conditions: Diabetic Foot Ulcer
Sex: All
Ages: 18 Years – 89 Years
Healthy volunteers: Yes
Enrollment: 700
Sponsor: University of Texas Southwestern Medical Center
Location: UT Southwestern Medical Center at Dallas Dallas Texas
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 Criteria
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
Source: ClinicalTrials.gov (NCT04232631). StuddyBuddy aggregates publicly available trial information.