Diabetic Foot Ulcer (DFU) Rapid Pathogen Identification

Description

The purpose of this study is to evaluate the role of rapid diagnosis of pathogens in treatment of infection and wound healing in diabetic foot ulcers. This research is studying the use of a new device of people to learn if metagenomic next generation sequencing (mNGS) techniques technology is a feasible tool that can be used to direct targeted antibiotic therapy in infected diabetic foot ulcers. Participant's tissue will be randomized to usual care tissue collection and cultures (standard of care) or usual care tissue collection and cultures (standard of care) plus metagenomics next generation sequencing (mNGS). The participant's will not be randomized to any treatment (i.e. antibiotic therapy).

Conditions

Diabetic Foot Ulcer, Diabetes Mellitus, Wound

Study Overview

Study Details

Study overview

The purpose of this study is to evaluate the role of rapid diagnosis of pathogens in treatment of infection and wound healing in diabetic foot ulcers. This research is studying the use of a new device of people to learn if metagenomic next generation sequencing (mNGS) techniques technology is a feasible tool that can be used to direct targeted antibiotic therapy in infected diabetic foot ulcers. Participant's tissue will be randomized to usual care tissue collection and cultures (standard of care) or usual care tissue collection and cultures (standard of care) plus metagenomics next generation sequencing (mNGS). The participant's will not be randomized to any treatment (i.e. antibiotic therapy).

The Role of the Microbiome in Diabetic Foot Ulcers

Diabetic Foot Ulcer (DFU) Rapid Pathogen Identification

Condition
Diabetic Foot Ulcer
Intervention / Treatment

-

Contacts and Locations

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48106

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Patients with diabetes mellitus
  • * Have an infected DFU with a surface area ≥0.5 square centimeter (cm2)
  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Michigan,

Brian Schmidt, DPM, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

2025-09