# The Role of the Microbiome in Diabetic Foot Ulcers

> **NIH NIH K23** · UNIVERSITY OF MICHIGAN AT ANN ARBOR · 2022 · $194,908

## Abstract

PROJECT SUMMARY / ABSTRACT
 Diabetic foot ulcers (DFUs) remain one of the most common complications of diabetes mellitus (DM) and are
the leading cause of lower extremity amputation with every sixth individual suffering an early demise as a result.
Many complicating factors of DM contribute and interrupt normal physiologic healing processes. Five-year
mortality after DFU occurrence is 40% and is 10-fold higher than non-diabetic cohorts. Despite major scientific
advances in the understanding of wound healing physiology, only one-half of DFUs heal when standard of care
is met. This unfortunate truth highlights the need to identify modifiable risk factors for healing that may be the
cause of non-healing events in the treatment of DFUs.
 The DFU microbiome may represent these important modifiable risk factors in obtaining wound healing. The
DFU microbiome is comprised of the genetic material of all the microbiota that cohabitate the DFU. Past
observational studies have implicated one or more of these microbiotas as contributors to non-healing, but these
studies have suffered from significant design limitations and lack consensus assessment. Most studies were
only cross-sectional in design and focused primarily on non-infected DFUs. Furthermore, these studies did not
collect biospecimens consistently across studies. In this career development, we propose to understand the role
of the microbiome in the pathogenesis of DFU and understand the trajectories of the microbiome across DFU
wound progression in three aims. Aim 1 will perform a cross-sectional cohort of patients with DFU to compare
the microbiome of those with DFI to infection-free DFUs using metagenomics next generation sequencing
(mNGS). Aim 2 will leverage this initial cohort to longitudinally determine the temporal relationships and
interactions between pathogen presence, wound healing, and development of infection. Aim 3 will assess the
clinical feasibility of using mNGS to predict antibiotic therapy against identified pathogens in infected DFU in a
pilot clinical trial. The overall goal of this project is to identify modifiable risk factors in the DFU microbiome that
will lead to interventional clinical trials to prevent and/or treat DFUs.
 This proposal is essential to my career development. I will become an independent clinical researcher with
expertise in diabetic foot complications. The formal training in clinical trial execution and biostatistics will provide
practical experiences and will set the stage for successful completion of not only this project, but also of future
investigations. The clinical trial component of my career development will allow me to take the results from this
study and seamlessly transition into interventional studies that will lead to new treatments for patients suffering
from DFUs. Drs. Rodica Pop-Busui and Keith Kaye are ideally suited as mentors for this project with their
complementary expertise in diabetes, neuropathy, infectious disease, and clinical t...

## Key facts

- **NIH application ID:** 10523375
- **Project number:** 1K23DK131261-01A1
- **Recipient organization:** UNIVERSITY OF MICHIGAN AT ANN ARBOR
- **Principal Investigator:** Brian M Schmidt
- **Activity code:** K23 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $194,908
- **Award type:** 1
- **Project period:** 2022-09-15 → 2027-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10523375

## Citation

> US National Institutes of Health, RePORTER application 10523375, The Role of the Microbiome in Diabetic Foot Ulcers (1K23DK131261-01A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10523375. Licensed CC0.

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