Non-Invasive Testing to Evaluate Wound Healing in Diabetes
Key facts
- Who runs it
- University of Texas Southwestern Medical Center
- Where
- Dallas, United StatesSee the site
- Trial code
- Status
- Terminated
- People taking part
- 157 people enrolled
- Started
- 28 Apr 2021
- Ended
- 2 Nov 2026
- Type of study
- Observational, 2 groups
- Treatments tested
- SnapshotNIR, Kent Imaging
- Record updated
- 13 November 2026
- Why it stopped
- Study was stopped as the company that owns the hyperspectral imaging devices required their return.
Who can take part
- Age
- 18 years to 89 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- Patient of the investigators
- Diagnosis of diabetes mellitus
- One or more moderate to severe diabetic foot ulcers/infections
- 18-89 years of age
- Over 18
- Have a foot
Who cannot take part
- 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
- Patients with a history of poor compliance; Normal Healthy volunteers
- Non-diabetic
- Is pregnant or plans to become pregnant
- Is nursing or actively lactating
- 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
- Foot wounds
- Non-English speaking
Other criteria
- Investigator patients
Where in United States
- UT Southwestern Medical Center at DallasDallas, United States
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- patients with diabetic foot ulcers
* Patient of the investigators * Diagnosis of diabetes mellitus * One or more moderate to severe diabetic foot ulcers/infections * 18-89 years of age
Treatment: SnapshotNIR, Kent Imaging
- Normal healthy volunteers
over 18 years of age have a foot
Treatment: SnapshotNIR, Kent Imaging
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 13 November 2026