Non-Invasive Testing to Evaluate Wound Healing in Diabetes

Recruiting now

Conditions studied: Diabetic Foot Ulcer

In brief

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.

Key facts

Study ID

NCT04232631

Run by

University of Texas Southwestern Medical Center

People needed

700

Starts

2021-04-28

Expected to finish

2026-09-01

Last updated by the study team

2025-08-13

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patient of the investigators
• Diagnosis of diabetes mellitus
• One or more moderate to severe diabetic foot ulcers/infections
• 18-89 years of age

You may not qualify if…

• 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

Where it is running

• UT Southwestern Medical Center at Dallas — Dallas, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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