Wednesday, May 21, 2025 5/21/2025

University of Michigan Data Coordinating Center for the Diabetic Foot Consortium

Award Number: U24DK122927
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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University of Michigan Data Coordinating Center for the Diabetic Foot Consortium - Diabetes-related foot ulcers (DFUs) are prevalent and devastating complications of diabetes, with few FDA-approved therapies. The Diabetic Foot Consortium (DFC) was established in 2018 as the first multi-site US clinical research effort to elucidate biomarkers that promote DFU healing and prevent recurrence. The multiplicity and complexity of known factors contributing to poor outcomes require the diversity of experience and expertise of the four DFC clinical research units (CRUs), the biomarker analysis units (BAUs), and the University of Michigan (UM) data coordinating center (DCC) to achieve the scientific objectives of the DFC. The DCC brings over 23 years of experience in statistical and operational leadership of complex studies and networks, leveraging specific experience in diabetes complications and co-morbidity modeling, design and analysis of chronic diseases, biomarker discovery and validation, and FDA collaborations. The DCC’s leadership in these areas complements the clinical and laboratory expertise of the DFC. Together we will identify important and reliable biomarkers that predict DFU healing and recurrence and study the association of patient and physician characteristics with good DFU outcomes. In our first 3 years, the DCC has built successful and durable partnerships with CRU and BAU investigators and NIDDK scientists to implement two biomarker validation studies and a biorepository study that collects biospecimens for future research. We will continue this partnership to complete these complex studies and finalize a platform study in patients with open DFUs that will support future biomarker studies, as well further our knowledge of the impact of standard of care therapies and social determinants of health on DFU outcomes. These activities will lay the foundation for future trials leading to better care and health outcomes for patients with DFUs. We will accomplish these goals by: 1) providing tailored infrastructure and services to ensure seamless administration and operations for all DFC studies and facilitate effective communication among DFC stakeholders; 2) ensuring the collection of timely, accurate and reproducible data and high-quality biospecimens and maximizing adherence to study protocols by providing expert statistical design, efficient database architecture, and effective study coordination; 3) applying state-of-the-art bioinformatics and statistical methods to analyze biomarker qualification, to detect important patient characteristics associated with good clinical outcomes, and to identify testable hypotheses to guide care for subpopulations of patients with DFUs. 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 improvements in standard of care based on comprehensive patient, foot ulcer and treatment data. Collaboration among the CRUs, BAUs, satellite sites, ancillary study investigators, NIDDK and DCC will maximize the scientific and clinical impact of the Consortium in this complex and challenging therapeutic area.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $3,790,120 )
2025	2025	REGENTS OF THE UNIVERSITY OF MICHIGAN	1109 GEDDES AVE STE 3300	ANN ARBOR	MI	48109	WASHTENAW	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	7	2/20/2025	NON-COMPETING CONTINUATION	$3,790,120
														Subtotal = $3,790,120

Issue Date FY: 2024 ( Subtotal = $3,861,668 )
2024	2024	REGENTS OF THE UNIVERSITY OF MICHIGAN	1109 GEDDES AVE, SUITE 3300	ANN ARBOR	MI	48109	WASHTENAW	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	6	1/18/2024	NON-COMPETING CONTINUATION	$3,861,668
2024	2023	REGENTS OF THE UNIVERSITY OF MICHIGAN	1109 GEDDES AVE, SUITE 3300	ANN ARBOR	MI	48109	WASHTENAW	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	5	1/11/2024	COMPETING CONTINUATION	$515,140
2024	2022	REGENTS OF THE UNIVERSITY OF MICHIGAN	1109 GEDDES AVE, SUITE 3300	ANN ARBOR	MI	48109	WASHTENAW	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	1/11/2024	NON-COMPETING CONTINUATION	-$515,140
														Subtotal = $3,861,668

Issue Date FY: 2023 ( Subtotal = $3,906,835 )
2023	2023	REGENTS OF THE UNIVERSITY OF MICHIGAN	1109 GEDDES AVE, SUITE 3300	ANN ARBOR	MI	48109	WASHTENAW	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	004	5	8/10/2023	SUPPLEMENT FOR EXPANSION	$138,934
2023	2023	REGENTS OF THE UNIVERSITY OF MICHIGAN	1109 GEDDES AVE, SUITE 3300	ANN ARBOR	MI	48109	WASHTENAW	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	005	5	9/23/2023	COMPETING CONTINUATION	$0
2023	2023	REGENTS OF THE UNIVERSITY OF MICHIGAN	1109 GEDDES AVE, SUITE 3300	ANN ARBOR	MI	48109	WASHTENAW	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	5	6/14/2023	COMPETING CONTINUATION	$0
2023	2023	REGENTS OF THE UNIVERSITY OF MICHIGAN	1109 GEDDES AVE, SUITE 3300	ANN ARBOR	MI	48109	WASHTENAW	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	003	5	7/28/2023	COMPETING CONTINUATION	$0
2023	2023	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON STREET	ANN ARBOR	MI	48109	WASHTENAW	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	5	3/15/2023	COMPETING CONTINUATION	$3,767,901
2023	2022	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON STREET	ANN ARBOR	MI	48109	WASHTENAW	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	3/8/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $3,906,835

Issue Date FY: 2022 ( Subtotal = $556,630 )
2022	2022	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	4	8/2/2022	NON-COMPETING CONTINUATION	$556,630
2022	2022	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	004	4	8/29/2022	NON-COMPETING CONTINUATION	$0
2022	2022	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	003	4	8/24/2022	NON-COMPETING CONTINUATION	$0
2022	2021	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	3	4/28/2022	NON-COMPETING CONTINUATION	$0
2022	2021	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	2/14/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $556,630

Issue Date FY: 2021 ( Subtotal = $1,439,556 )
2021	2021	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	3	7/7/2021	NON-COMPETING CONTINUATION	$1,439,556
2021	2020	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	5/27/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,439,556

Issue Date FY: 2020 ( Subtotal = $1,396,445 )
2020	2020	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	2	7/1/2020	NON-COMPETING CONTINUATION	$731,569
2020	2020	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	4/23/2020	SUPPLEMENT FOR EXPANSION	$626,505
2020	2020	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	2	8/31/2020	NON-COMPETING CONTINUATION	$38,371
														Subtotal = $1,396,445

Issue Date FY: 2019 ( Subtotal = $749,449 )
2019	2019	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	1	9/13/2019	NEW	$264,000
2019	2019	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	6/12/2019	NEW	$485,449
														Subtotal = $749,449

Grand Total All Awards = $15,700,703

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University of Michigan Data Coordinating Center for the Diabetic Foot Consortium

Award Number: U24DK122927

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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