Evaluating wound healing in diabetic patients using non-invasive imaging
Non-Invasive Testing to Evaluate Wound Healing in Diabetes
This study is testing a special imaging device to see how well diabetic foot ulcers heal in people with diabetes and healthy volunteers over six months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 700 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT04232631 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect data on wound healing in patients with diabetic foot ulcers using a non-contact imaging device called SnapshotNIR. The study will enroll up to 500 participants, including healthy volunteers and patients diagnosed with diabetes who have moderate to severe foot ulcers. Data will be collected at various stages, including preoperative, intraoperative (if feasible), and during follow-up visits for up to six months. The goal is to assess perfusion and predict healing outcomes without impacting standard medical care.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-89 with diabetes and one or more moderate to severe diabetic foot ulcers.
Not a fit: Patients who are non-diabetic, pregnant, or have significant psychological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method to predict wound healing and improve management of diabetic foot ulcers.
How similar studies have performed: Other studies using non-invasive imaging techniques have shown promise in assessing wound healing, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dallas, Texas
- UT Southwestern Medical Center at Dallas — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Andrew P Crisologo, DPM — University of Texas Southwestern Medical Center
- Study coordinator: Debby Noble
- Email: Debby.Noble@UTSouthwestern.edu
- Phone: 2146488686
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.