# NIDDK Diabetic Foot Consortium Clinical Research Unit

> **NIH NIH U01** · UNIVERSITY OF MICHIGAN AT ANN ARBOR · 2024 · $727,080

## Abstract

ABSTRACT
Diabetic foot ulcers (DFUs) are a prevalent diabetes complications affecting up to 35% of people with diabetes.
Considering the continuous increase in diabetes prevalence and incidence reaching pandemic rates worldwide,
the healthcare and socioeconomic impact are staggering, with ~80,000 Americans sustaining non-traumatic
amputations each year, and five-year mortality rates of up to 40%. Diabetic foot ulcers (DFUs) costs alone are
estimated to add $9 billion-$13 billion per year to the rest of costs to manage diabetes. Additionally, after decades
of sustained decline, most recent evidence show that non-traumatic lower extremity amputations in diabetes are
now on the rise, despite advances in the standards of diabetes care, recognition for the need of interdisciplinary
care teams, and research to target wound care products. Thus, continuing the work and expanding our
accomplishments during the first cycle of the Diabetic Foot Consortium (DFC) Clinical Research Unit to validate
and implement sensitive DFUs biomarkers at the point of care cannot be understated.
The main objectives of the DFU Clinical Research Unit (CRU) at the University of Michigan are to expand the
work and activities initiated during the first cycle by integrating the robust DFC infrastructure we built at Michigan
with the highly skilled clinical and translational research team to: finalize the ongoing DFU biomarkers protocols;
implement the DFC master protocol and its various substudies; continue our high recruitment performance
across all ongoing and new biomarker studies; recruit, train and supervise satellite sub sites; develop new
methods to stimulate participants engagement and adherence; refine large and standardized biological, imaging,
and clinical samples collections, including patient reported outcomes and social determinants of health; analyze
how DFU recommended standards of care are implemented into usual care; active and effective participation in
DFC self-governing committees. Additionally, will participate in biomarker validation analyses and apply novel
discovery tools and analyses including machine learning techniques through a multidisciplinary approach to
identify new phenotyping, genomic, molecular and microbiome biomarkers from all DFUs biosamples and wound
images to be implemented at point of care. We will also leverage the large and diverse pool of people with
diabetes foot complications that receive care at the entire University of Michigan Health System, enabling us to
recruit for any ongoing and new DFU studies proposed in the renewal. Our continuous participation as a DFC
CRU, will enable us to build upon the state-of -the-art infrastructure, and the high record of success and
leadership we established over the past four years to continue to impact progress in all facets of DFUs from
research, to personalized treatment implementation and prevention, ultimately contributing to the great success
of the entire DFC network.

## Key facts

- **NIH application ID:** 10802197
- **Project number:** 5U01DK119083-07
- **Recipient organization:** UNIVERSITY OF MICHIGAN AT ANN ARBOR
- **Principal Investigator:** RODICA BUSUI (POP-BUSUI)
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $727,080
- **Award type:** 5
- **Project period:** 2018-09-15 → 2027-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10802197

## Citation

> US National Institutes of Health, RePORTER application 10802197, NIDDK Diabetic Foot Consortium Clinical Research Unit (5U01DK119083-07). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10802197. Licensed CC0.

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