# UCSF Diabetic Foot Clinical Research Unit

> **NIH NIH U01** · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · 2020 · $444,125

## Abstract

PROJECT ABSTRACT
Diabetic foot ulcers (DFU) are a common, disabling, and costly condition. They result from a confluence of
neuropathy, immunopathy, and vasculopathy that afflict the diabetic foot. Between 15-25% of individuals with
diabetes will get a DFU at some point during their lifetime, and up to 20% of these DFUs will lead to a major
limb amputation. DFUs require considerable time and resources to heal, and up to 80% of those that heal may
develop recurrence. As the global prevalence of diabetes continues to grow, the burden of DFU mandates
more effective prevention and treatment approaches. Evolving technologies in areas such as molecular
medicine, biomaterials, and biosensors offer opportunities to improve prevention and prognosis, accelerate
healing, and reduce recurrence. However, the development of effective treatments for DFU has been
hampered by challenges in clinical trials, including the need for better staging, validated surrogate biomarkers,
and standardized endpoints. The Diabetic Foot Consortium (DFC) is being established by NIDDK to address
this unmet need via a network of Clinical Research Units (CRUs), initially focused on biomarker studies. In this
application, the investigators propose the UCSF Diabetic Foot Clinical Research Unit, which leverages a
very diverse patient population, world-class institutions for clinical and translational science, and an
experienced, multi-disciplinary team of investigators and staff. The UCSF Diabetic Foot CRU includes the
University of California, San Francisco (UCSF) Medical Center and Zuckerberg San Francisco General (ZSFG)
Hospital as integrated performance sites. It builds upon existing centers of clinical and research expertise,
including the UCSF Center for Limb Preservation; the UCSF Diabetes Center; the UCSF Center for Vulnerable
Populations; the UCSF Clinical and Translational Science Institute (CTSI); and an NIDDK-funded Center for
Type 2 Diabetes Translational Research (CDTR). The investigators bring a broad range of expertise in
diabetes, vascular disease, podiatric medicine/surgery, clinical trials, research measurements in
ethnically/socio-economically diverse patients, and biomarker and wound healing studies of direct relevance to
the goals of the DFC. They propose a Diabetic Foot CRU that will utilize coordinated management and
innovative clinical research strategies to address three Specific Aims: i) recruitment of a socio-economically
and ethnically diverse and representative population for biomarker studies in DFU; ii) retention of subjects for
longitudinal cohort studies with repeated measures; and iii) efficient, quality-controlled, sample and data
collection to enable biomarker validation studies. In addition, the investigators will contribute to the DFC by
suggesting relevant biomarkers, technologies, and study protocols and trial designs to advance the clinical
science of DFU care.

## Key facts

- **NIH application ID:** 9947745
- **Project number:** 5U01DK119100-03
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
- **Principal Investigator:** Michael S Conte
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $444,125
- **Award type:** 5
- **Project period:** 2018-09-15 → 2022-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9947745

## Citation

> US National Institutes of Health, RePORTER application 9947745, UCSF Diabetic Foot Clinical Research Unit (5U01DK119100-03). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9947745. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*