# Circulating urinary microRNAs as systemic biomarkers of healing outcomes in diabetic foot ulcers

> **NIH NIH R33** · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · 2024 · $379,716

## Abstract

Project summary
Diabetic foot ulcers (DFUs) are a widespread, serious, and common complication of diabetes. Diabetes-related
amputations are associated with disability, drastic reduction in quality of life, high morbidity and resulting
alarming mortality rate of 35% over 5 years. Non-invasive detectable biomarkers that correlate with healing
outcomes of DFU are critically needed for early targeting of hard-to-heal ulcers for advanced interventions
beyond standard of care (SOC) therapy, as well as for timely monitoring of response to treatment. Preliminary
evidence developed in our laboratory supports circulating urinary microRNAs (miRNAs) as detectable
biomarkers for DFUs and other diabetes-associated complications; these miRNAs can be isolated and
quantified from urine in a technically robust and reproducible manner. Utilizing an R61/R33 funding mechanism
in response to RFA-DK-21-001, this project will capitalize upon patient enrollment in the existing protocols and
infrastructure of the Diabetic Foot Consortium to develop a practical, quantitative, non-invasive, cost-effective
prognostic biomarker comprised of a urinary microRNA subset that, when assessed in patients at baseline,
accurately and reliably differentiates DFUs that have the capacity to heal with SOC from those that do not.
Specifically, in R61/ Exploratory phase, a combined data reduction and prognostic modeling approach will be
applied to narrow the determine miRNome of top 10-20 miRNA parameters that predict DFU clinical healing
outcomes at Week 12. Sensitivity, specificity, and accuracy of predictions will be evaluated and with
successful completion of R61 milestones the model will progress to the R33/Validation phase, in which the
custom miRNA subset biomarker panel will be interrogated for its ability to predict healing outcomes in a
prospectively enrolled cohort of 100 additional patients with open DFUs. Results of the Validation phase will
yield a biomarker ready for submission for FDA biomarker qualification approval and subsequent direct clinical
implementation as a point-of-care assessment to guide clinical management decisions and improve wound
closure outcomes, thereby reducing associated DFU morbidity and mortality.

## Key facts

- **NIH application ID:** 11159351
- **Project number:** 4R33DK131897-03
- **Recipient organization:** UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
- **Principal Investigator:** Rivka C. Stone
- **Activity code:** R33 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $379,716
- **Award type:** 4N
- **Project period:** 2022-07-04 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11159351

## Citation

> US National Institutes of Health, RePORTER application 11159351, Circulating urinary microRNAs as systemic biomarkers of healing outcomes in diabetic foot ulcers (4R33DK131897-03). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/11159351. Licensed CC0.

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