Biomarkers for Diabetic Foot Ulcers through the Diabetic Foot Consortium (R61/R33 Clinical Trial Not Allowed) | RFA DK 21 001

Opportunity Information: Apply for RFA DK 21 001

The NIH funding opportunity "Biomarkers for Diabetic Foot Ulcers through the Diabetic Foot Consortium (R61/R33 Clinical Trial Not Allowed)" (RFA-DK-21-001; CFDA 93.847) is a discretionary grant program focused on accelerating the development of biomarkers that can meaningfully improve how diabetic foot ulcers (DFUs) are studied and managed. The central aim is to move promising DFU biomarker candidates far enough along the pipeline that they are ready for more definitive analytical validation and clinical validation studies, with an emphasis on real-world usability in clinical trials and patient care. Rather than supporting large clinical trials, the announcement is geared toward early-stage but rigorous biomarker work that produces credible, decision-ready candidates.

Scientifically, the program targets three broad biomarker use cases: prognostic biomarkers that help predict outcomes such as healing, infection, recurrence, amputation risk, or time-to-closure; monitoring biomarkers that track disease status and response to therapy over time; and diagnostic biomarkers that aid in identifying clinically relevant states (for example, distinguishing non-healing phenotypes, detecting infection-related processes, or differentiating ulcer types or complications). The intent is not just discovery for its own sake, but development that demonstrates a clear path to application, including evidence that a biomarker can be measured reliably and interpreted consistently enough to support clinical decision-making or trial endpoints.

A defining feature of this opportunity is its use of a phased R61/R33 mechanism. In practical terms, this structure supports a milestone-driven progression, where the initial phase emphasizes feasibility and early validation work (such as assay development, analytical performance, and preliminary clinical associations), and the later phase supports expansion and strengthening of validation evidence once predefined goals are met. This phased approach is designed to encourage innovative ideas while still holding projects to concrete deliverables, reducing the risk that biomarker concepts stall before they become genuinely actionable.

Another major component is the explicit linkage to the Diabetic Foot Consortium. The FOA emphasizes leveraging consortium resources to access well-characterized patient cohorts and high-quality human samples. That matters because DFU biomarker studies often fail when they rely on poorly standardized sample handling, heterogeneous clinical phenotyping, or limited follow-up data. By connecting projects to a consortium infrastructure, the program is aiming to improve reproducibility, ensure higher-quality clinical annotation, and speed up progress by reducing common logistical barriers to obtaining appropriate samples and patient-level data.

Administratively, the opportunity is issued by the National Institutes of Health, uses the grant funding instrument, and falls under the health and nutrition/health activity category. The original closing date listed is 2021-11-03, and the award ceiling shown in the source data is $325,000. The listing indicates expected awards but does not provide a number in the provided text. The "Clinical Trial Not Allowed" designation signals that applicants should propose biomarker development and validation activities that do not meet NIH’s definition of a clinical trial, meaning the work should center on assay/biomarker performance and observational or specimen-based validation rather than prospectively assigning interventions to human participants to evaluate health outcomes.

Eligibility is broad and includes many types of domestic organizations and governmental entities, such as state, county, city/township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; public housing authorities/Indian housing authorities; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations (other than small businesses); and small businesses. The FOA also explicitly highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISISs, Hispanic-serving Institutions, HBCUs, TCCUs, faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, regional organizations, non-federally recognized tribal governments, and even non-U.S. entities (foreign organizations). Overall, the program is structured to pull in a wide range of scientific, clinical, and translational expertise while channeling efforts toward a concrete outcome: DFU biomarker candidates that are sufficiently mature to proceed into definitive validation through the Diabetic Foot Consortium.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Biomarkers for Diabetic Foot Ulcers through the Diabetic Foot Consortium (R61/R33 Clinical Trial Not Allowed)" 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 2021-01-13.
• Applicants must submit their applications by 2021-11-03. (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 $325,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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