NCT04232631 Non-Invasive Testing to Evaluate Wound Healing in Diabetes
| NCT ID | NCT04232631 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Texas Southwestern Medical Center |
| Condition | Diabetic Foot Ulcer |
| Study Type | OBSERVATIONAL |
| Enrollment | 700 participants |
| Start Date | 2021-04-28 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 700 participants in total. It began in 2021-04-28 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Contact & Investigator
Andrew P Crisologo, DPM
PRINCIPAL INVESTIGATOR
University of Texas Southwestern Medical Center
Frequently Asked Questions
Who can join the NCT04232631 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 89 Years, studying Diabetic Foot Ulcer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04232631 currently recruiting?
Yes, NCT04232631 is actively recruiting participants. Contact the research team at Debby.Noble@UTSouthwestern.edu for enrollment information.
Where is the NCT04232631 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT04232631 clinical trial?
NCT04232631 is sponsored by University of Texas Southwestern Medical Center. The principal investigator is Andrew P Crisologo, DPM at University of Texas Southwestern Medical Center. The trial plans to enroll 700 participants.