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Search / Trial NCT06569238

Diabetic Foot Ulcer (DFU) Rapid Pathogen Identification

Launched by UNIVERSITY OF MICHIGAN · Aug 21, 2024

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Wound Infection Wound Assessments Wound's Microbiome Next Generation Sequencing

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.

Locations

Ann Arbor, Michigan, United States

Patients applied

0 patients applied

Trial Officials

Brian Schmidt, DPM

Principal Investigator

University of Michigan

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported