Non-Invasive Testing to Evaluate Wound Healing in Diabetes
Recruiting
Observational Study
Diabetic Foot Ulcer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 89
Sex
Any
Study type
Observational
Participants needed
700 (estimated)
Sponsor
University of Texas Southwestern Medical Center · Other
Who this trial is looking for
This trial is looking for people with diabetes who have moderate to severe foot ulcers. Participants will provide images and medical information about their wounds and health history.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 89 years old.
I have been diagnosed with diabetes mellitus.
I have one or more moderate to severe diabetic foot ulcers.
You may not be able to join if
I am not diabetic.
I am pregnant or planning to become pregnant.
I am nursing or actively lactating.
I have a significant psychological disorder.
I have active alcohol or substance abuse.
I have a history of poor compliance.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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, Albert…
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.
Trial Locations
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Facility
City
State
Country
Status
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 la…
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
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