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Non-Invasive Testing to Evaluate Wound Healing in Diabetes

RECRUITINGSponsored by University of Texas Southwestern Medical Center
Actively Recruiting
SponsorUniversity of Texas Southwestern Medical Center
Started2021-04-28
Est. completion2026-09
Eligibility
Age18 Years – 89 Years
Healthy vol.Accepted
Locations1 site

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

Age: 18 Years – 89 YearsHealthy volunteers accepted
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

Conditions2

DiabetesDiabetic Foot Ulcer

Locations1 site

UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390
Debby Noble214-648-8686debby.noble@UTSouthwestern.edu

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