# University of Michigan Data Coordinating Center for the Diabetic Foot Consortium

> **NIH NIH U24** · UNIVERSITY OF MICHIGAN AT ANN ARBOR · 2022 · $556,630

## Abstract

Diabetes-related foot ulcers (DFUs) are prevalent and devastating complications of diabetes, with few
FDA-approved technologies and therapies to promote successful healing or prevention. The Diabetic Foot
Consortium (DFC) represents the first-of-its-kind multi-site clinical research effort in the US to elucidate
biomarkers that promote DFU healing and prevent recurrence. Given the multiplicity and complexity of known
factors contributing to non-healing (including biomarkers, disease state, health care delivery, interventions,
behavioral and psychosocial factors), the breadth and diversity of experience and expertise of the six clinical
sites chosen as DFC clinical research units (CRUs) are essential to achieve the objectives of the consortium.
 Rigorous design, accompanied by thoughtful statistical analyses, of biomarker validation studies are
also critical to accomplish DFC goals. With more than 20 years of experience, the University of Michigan data
coordinating center (DCC) brings together an exemplary research group. DCC investigators have relevant
experience in diabetes complications and co-morbidity modeling, design and analysis of chronic diseases,
biomarker discovery and validation, and FDA collaborations. Strong statistical leadership complements the
clinical and laboratory expertise of the DFC, leading to enhanced understanding of the pathophysiology of DFU
healing, dissemination of clinically relevant results, and preparation for translational clinical studies. The
overarching goal of the DCC is to assist and collaborate with clinical research and biomarker analysis unit
investigators, the DFC steering committee, and NIDDK program staff to enable successful implementation and
completion of the clinical study protocols approved by the DFC, and advise and execute biomarker validation
analyses.
 We will accomplish these goals through by 1) providing infrastructure and services to the DFC, tailored
for their goals. This will ensure seamless study administration and operations for all DFC studies, and promote
effective communication among DFC stakeholders. 2) We will ensure the collection of timely, accurate and
reproducible data and maximize adherence to study protocols by providing expert statistical design, efficient
database architecture, and effective study coordination. 3) We will conduct statistical data analyses and
disseminate research findings with scientific rigor for biomarker qualification using the most up-to-date
statistical methods. Completion of these aims by a highly experienced and accomplished UM DCC will result in
translation of the validated biomarkers from bench to bedside, and maximization of the clinical impact of the
consortium in this complex and challenging therapeutic area.

## Key facts

- **NIH application ID:** 10614917
- **Project number:** 5U24DK122927-04
- **Recipient organization:** UNIVERSITY OF MICHIGAN AT ANN ARBOR
- **Principal Investigator:** Catherine A Spino
- **Activity code:** U24 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $556,630
- **Award type:** 5
- **Project period:** 2019-07-01 → 2023-03-15

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10614917

## Citation

> US National Institutes of Health, RePORTER application 10614917, University of Michigan Data Coordinating Center for the Diabetic Foot Consortium (5U24DK122927-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10614917. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*