Limited Competition for the Continuation of the NIDDK Diabetic Foot Consortium - Clinical Research Units (U01 Clinical Trial Optional) | RFA DK 22 509

Opportunity Information: Apply for RFA DK 22 509

This funding opportunity, RFA-DK-22-509, is a limited competition National Institutes of Health (NIH) announcement from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to continue and renew the Clinical Research Units (CRUs) that make up the Diabetic Foot Consortium (DFC). The award mechanism is a U01 cooperative agreement, meaning funded sites will not operate in isolation like a traditional grant; instead, they will work in close partnership with NIH and the rest of the consortium under a coordinated, network-style governance structure. The clinical trial component is described as optional, leaving room for the network to conduct observational studies now while also being positioned to run trials later as protocols mature.

At the center of the program is the public health burden of diabetic foot ulcers (DFUs), which are among the most serious and costly complications of diabetes and are associated with more than 100,000 amputations each year in the United States. The DFC was originally created to build the kind of shared clinical research infrastructure that is hard for any single institution to assemble on its own, and to validate biomarkers that could help predict whether a wound will heal or recur. This renewal expands the consortiums mission beyond its initial foundation-building phase into a broader effort aimed at improving prediction, care, and outcomes for people with DFUs.

The FOA lays out four major goals for the renewed and expanded DFC. First, the consortium will develop and validate biomarkers related to DFUs, with an emphasis on markers that can meaningfully predict healing trajectories and recurrence risk. Second, it aims to accelerate advances in standard care for DFUs, which implies not only testing new approaches when appropriate, but also improving how evidence-based care is implemented and evaluated across real-world clinical settings. Third, the DFC will more directly examine how social determinants of health influence DFU healing and recurrence, acknowledging that factors such as access to care, socioeconomic constraints, transportation, housing stability, health literacy, and other structural issues can strongly shape wound outcomes. Fourth, the DFC is expected to extend the value of its infrastructure through ancillary studies and the use of satellite sites, allowing the network to address additional scientific questions and broaden recruitment capacity without rebuilding the core system each time.

The CRUs are the operational backbone for all consortium protocols. In practical terms, they are the places where participants are identified and enrolled, study visits occur, and the day-to-day clinical research work happens. The CRUs will be responsible for recruiting participants, collecting longitudinal clinical data over time, capturing images (a critical component for DFU assessment and standardized wound tracking), and obtaining biospecimens. These data and biosamples are then routed to the networks central Data Coordinating Center and Biomarker Analysis Units so that information is harmonized, curated, and analyzed consistently across all sites. This structure is designed to make multi-site data comparable and to support biomarker validation efforts that require large, diverse cohorts and standardized methods.

A key feature of the renewal is the expectation that CRUs will collaborate with satellite sites. Satellite sites can expand the networks footprint, increase the pace of enrollment, and improve representation of different patient populations and care settings, which is especially important when studying both biological predictors and social determinants of health. The CRUs are expected to serve as hubs for those satellite relationships, helping align procedures, training, data capture, and sample handling so that satellite contributions fit seamlessly into consortium-wide protocols.

Governance and scientific direction are also part of the CRU role. CRUs will participate in the DFC Steering Committee, where they will help provide leadership in developing new protocols, refining existing ones, and setting scientific priorities for the network. Because this is a cooperative agreement, that steering structure matters: it is how the consortium decides what studies to launch, how to allocate shared resources, and how to ensure the network is collectively working toward deliverables that can improve clinical research and ultimately patient care for DFUs.

Eligibility is restricted in important ways. The announcement specifies that non-U.S. entities (foreign institutions) are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible to apply. At the same time, foreign components, as NIH defines them in policy, are allowed, which generally means U.S.-led applicants may include certain international elements when justified and compliant, even though the applicant organization itself must be domestic. The opportunity is labeled as a limited competition, which typically means only a defined set of applicants (often current consortium members or specifically invited/qualified entities) are intended to apply, rather than the broader research community.

From the administrative details provided, the opportunity falls under CFDA 93.847 and is categorized under health (and listed with food and nutrition/health activity categories). The original closing date was August 17, 2022, and the listed award ceiling is $365,000. The overall emphasis, however, is less about a single standalone project and more about maintaining and strengthening a coordinated clinical network capable of running high-quality, multi-site DFU studies, producing validated biomarkers, improving standard care approaches, and capturing the real-world social and structural factors that influence healing and recurrence.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Limited Competition for the Continuation of the NIDDK Diabetic Foot Consortium - Clinical Research Units (U01 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847.
• This funding opportunity was created on 2022-06-07.
• Applicants must submit their applications by 2022-08-17. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $365,000.00 in funding.
• Eligible applicants include: Small businesses.

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