Diabetic Foot Ulcer (DFU) Rapid Pathogen Identification
Launched by UNIVERSITY OF MICHIGAN · Aug 21, 2024
Trial Information
Current as of July 25, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at how quickly identifying germs (or pathogens) can help treat infections and heal diabetic foot ulcers (DFUs). Researchers want to see if a new testing method called metagenomic next generation sequencing (mNGS) can help doctors choose the right antibiotics to fight the infection in these ulcers. Participants in the study will have their tissue samples tested in two ways: one group will receive standard care and the other group will receive standard care plus the new mNGS testing.
To participate in this trial, you need to have diabetes and an infected foot ulcer that is at least the size of a small coin. Your blood sugar level should be managed well, with a measurement called hemoglobin A1c (HbA1c) of 12% or less. The study is open to adults aged 65 to 74, and all genders are welcome. Participants will not be randomly assigned to any specific treatment, but they will need to follow study procedures. It’s important to note that pregnant women, those with uncontrolled blood sugar, or anyone currently infected with COVID-19 cannot join the study. If you're interested, this could be an opportunity to help improve treatments for diabetic foot ulcers.
Gender
ALL
Eligibility 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
About University Of Michigan
The University of Michigan, a leading academic institution renowned for its commitment to advancing healthcare and medical research, serves as a prominent clinical trial sponsor. With a robust infrastructure that supports innovative research initiatives, the university leverages its multidisciplinary expertise to conduct a wide array of clinical trials aimed at improving patient outcomes and advancing medical knowledge. Through its state-of-the-art facilities and collaborative environment, the University of Michigan fosters partnerships between researchers, clinicians, and industry leaders, ensuring the development of cutting-edge therapies and interventions that address pressing health challenges.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ann Arbor, Michigan, United States
Patients applied
Trial Officials
Brian Schmidt, DPM
Principal Investigator
University of Michigan
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported