Rapid identification of pathogens in diabetic foot ulcers
The Role of the Microbiome in Diabetic Foot Ulcers
This study is testing if quickly identifying germs in diabetic foot ulcers using advanced technology can help people heal better when compared to standard treatment alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 2 sites (Ann Arbor, Michigan and 1 other locations) |
| Trial ID | NCT06569238 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of rapid pathogen diagnosis using metagenomic next generation sequencing (mNGS) in treating infections and promoting wound healing in diabetic foot ulcers. Participants will be randomly assigned to receive either standard care or standard care plus mNGS for pathogen identification. The study will track participants for approximately 12 weeks, assessing their wounds and medical history. The results from mNGS will be shared with treating physicians to potentially adjust antibiotic therapy based on identified pathogens.
Who should consider this trial
Good fit: Ideal candidates include patients with diabetes mellitus who have an infected diabetic foot ulcer of at least 0.5 cm² in surface area.
Not a fit: Patients who are pregnant, have uncontrolled blood glucose, or are currently infected with COVID-19 may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more targeted and effective antibiotic treatments for patients with diabetic foot ulcers.
How similar studies have performed: Other studies have shown promise in using rapid diagnostic techniques for infections, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with diabetes mellitus * Have an infected DFU with a surface area ≥0.5 square centimeter (cm2) o DFU Infection status will be clinically recorded at time of enrollment according to Infectious Disease Society of America (IDSA): mild, moderate, or severe infection * Have a hemoglobin A1c\[HbA1c\] of 12% or less as measured within the last 6 months, * Stated willingness to comply with all study procedures and availability for the duration of the study Exclusion Criteria: * Pregnant or lactating * Uncontrolled blood glucose as demonstrated by a HbA1c of greater than 12% * Bilateral wound or ulcer * Current infection of Coronavirus disease 2019 (COVID19) * Unable to provide informed consent or are unwilling to participate
Where this trial is running
Ann Arbor, Michigan and 1 other locations
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Brian Schmidt, DPM — University of Michigan
- Study coordinator: Kourtney Noll
- Email: kneibaue@med.umich.edu
- Phone: 734-763-4156
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.