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NIDDK Diabetic Foot Consortium Clinical Research Unit

Award Number: U01DK119083
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/15/2018
PERIOD OF PERFORMANCE END DATE: 12/31/2027

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NIDDK Diabetic Foot Consortium Clinical Research Unit - 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.


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: 2026 ( Subtotal = $727,080 )
2026	2026	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	9	1/26/2026	NON-COMPETING CONTINUATION	$727,080
														Subtotal = $727,080

Issue Date FY: 2025 ( Subtotal = $727,080 )
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	002	8	6/2/2025	NON-COMPETING CONTINUATION	$0
2025	2025	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	8	1/9/2025	NON-COMPETING CONTINUATION	$727,080
2025	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	000	7	12/4/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $727,080

Issue Date FY: 2024 ( Subtotal = $727,080 )
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	004	7	1/18/2024	NON-COMPETING CONTINUATION	$727,080
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	002	6	10/26/2023	COMPETING CONTINUATION	$318,392
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	003	6	10/27/2023	COMPETING CONTINUATION	$0
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	001	5	10/26/2023	NON-COMPETING CONTINUATION	-$269,358
2024	2021	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	10/26/2023	NON-COMPETING CONTINUATION	-$49,034
														Subtotal = $727,080

Issue Date FY: 2023 ( Subtotal = $755,080 )
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	6	7/25/2023	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	6	3/10/2023	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	000	6	3/5/2023	COMPETING CONTINUATION	$555,400
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	6	8/18/2023	SUPPLEMENT FOR EXPANSION	$199,680
														Subtotal = $755,080

Issue Date FY: 2022 ( Subtotal = $269,358 )
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	5	8/2/2022	NON-COMPETING CONTINUATION	$269,358
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	4	4/29/2022	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	4	11/3/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $269,358

Issue Date FY: 2021 ( Subtotal = $591,862 )
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	4	7/16/2021	SUPPLEMENT FOR EXPANSION	$49,505
2021	2021	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	7/15/2021	NON-COMPETING CONTINUATION	$542,357
														Subtotal = $591,862

Issue Date FY: 2020 ( Subtotal = $867,157 )
2020	2020	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	003	3	8/17/2020	SUPPLEMENT FOR EXPANSION	$49,505
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	3	8/14/2020	SUPPLEMENT FOR EXPANSION	$388,652
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	3	6/25/2020	NON-COMPETING CONTINUATION	$429,000
2020	2019	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	12/20/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $867,157

Issue Date FY: 2019 ( Subtotal = $429,000 )
2019	2019	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	2	8/15/2019	NON-COMPETING CONTINUATION	$0
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	2	6/5/2019	NON-COMPETING CONTINUATION	$429,000
														Subtotal = $429,000

Issue Date FY: 2018 ( Subtotal = $423,400 )
2018	2018	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	9/11/2018	NEW	$423,400
														Subtotal = $423,400

Grand Total All Awards = $5,517,097

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NIDDK Diabetic Foot Consortium Clinical Research Unit

Award Number: U01DK119083

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/15/2018

PERIOD OF PERFORMANCE END DATE: 12/31/2027

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