# Integrated Clinical and Research Systems for Diabetic Foot Wound Care

> **NIH NIH U01** · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · 2020 · $430,375

## Abstract

Diabetes is a common, complex, and costly disease affecting 9.4% (30.3 millions) of Americans.
It remains the 7th leading cause of death in the United States, contributing to over 250,000 deaths
annually. Diabetic foot ulcers (DFU) are the most frequently recognized complication in diabetics
with an incidence of 6% in the diabetic global population, 6% among Medicare diabetic
beneficiaries, 5% among diabetic U.S. veterans and a lifetime incidence of foot ulcers between
19% and 34% in diabetics. The natural history of a diabetes-related foot ulcer is devastating. More
than half of ulcers become infected and approximately 20% of moderate or severe diabetic foot
infections lead to amputation. Mortality after diabetes-related amputations is greater than 70% at
5 years for all patients with diabetes, which is 2.5 times higher than in diabetic patients without a
foot ulcer. This proposal is designed to establish a clinical research unit (CRU) at the University
of Pittsburgh Medical Center that integrates high quality care delivery seamlessly with outstanding
clinical research. The CRU will then be a participating site in the NIH consortium studying
biomarkers for diabetic foot ulcer healing. Our central hypothesis is that we can address the
major challenges of diabetic foot ulcer clinical research through the seamless integration of wound
center clinical operations with research operations. Our specific aims are: Aim 1: Establish a
unified recruiting and retention system integrated with the clinical operations of our wound care
service line, and linked to our EPIC scheduling system and electronic medical record (EMR). Aim
2: Establish integrated research quality systems, linked to highly standardized clinical pathways,
and supported by a wound Informatics and Data Core connecting our 8 wound care centers.
By achieving these aims, we will have a high rate of enrollment of research subjects, collect useful
biomarker data, and be a valuable contributing member of the NIH research consortium.

## Key facts

- **NIH application ID:** 9959188
- **Project number:** 5U01DK119102-03
- **Recipient organization:** UNIVERSITY OF PITTSBURGH AT PITTSBURGH
- **Principal Investigator:** J PETER RUBIN
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $430,375
- **Award type:** 5
- **Project period:** 2018-09-15 → 2022-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9959188

## Citation

> US National Institutes of Health, RePORTER application 9959188, Integrated Clinical and Research Systems for Diabetic Foot Wound Care (5U01DK119102-03). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9959188. Licensed CC0.

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