# University of Miami Clinical Research Unit of the Diabetic Foot Consortium

> **NIH NIH U01** · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · 2020 · $109,226

## Abstract

Abstract
In response to RFA-DK-17-014, we propose the University of Miami Clinical Research Unit (UM-CRU) as a
site for the NIH Diabetic Foot Consortium (DFC) for future clinical study of selected biomarkers. The objective
of UM-CRU is to establish the organizational framework and infrastructure that will serve as a platform for
integrated multidisciplinary experimental clinical and translational research focusing on patients with diabetic
foot ulcers (DFU). The UM-CRU will, in conjunction with DFC develop the research design and study protocol,
and establish protocols for participant recruitment and follow-up, data collection, quality control, interim data
and safety monitoring, final data analysis and interpretation, and publication of results. Furthermore, UM-CRU
will facilitate procurement, storage and shipment of the biomaterials (tissue samples, swabs, wound fluid,
blood, serum and/or urine) as a part of the future biomarker studies. In addition, UM-CRU will establish and
maintain clinical data base that will allow overall data analyses of the DFC. The wound healing clinical
research team at the University of Miami has established a successful, decades-long track record of
conducting single- and multi-center clinical and translational trials for DFU and other types of chronic wounds.
Thus, UM-CRU provides unique expertise and infrastructure that can provide a platform for multi-center data
(clinical and biological) analyses. The overall structure of UM-CRU includes establishing an Administrative
Core to coordinate all aspects of the UM-CRU activities, regulatory clinical team, clinical investigator team and
translational research unit. The long-term goal of the UM-CRU is to provide a platform for innovation leading
to new therapeutic approaches and discoveries focusing on patients with DFU. The combination of
established outstanding group of clinicians and scientists, research tools, existing resources, capabilities,
supportive environment and collaborative expertise at UM represents a unique environment to greatly
advance the field of DFU related research. UM-CRU will provide outstanding clinical research base for all
proposed activities of the DFC.

## Key facts

- **NIH application ID:** 10214223
- **Project number:** 3U01DK119085-03S1
- **Recipient organization:** UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
- **Principal Investigator:** Robert Scott Kirsner
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $109,226
- **Award type:** 3
- **Project period:** 2018-09-15 → 2022-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10214223

## Citation

> US National Institutes of Health, RePORTER application 10214223, University of Miami Clinical Research Unit of the Diabetic Foot Consortium (3U01DK119085-03S1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10214223. Licensed CC0.

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