# Diabetic Foot Ulcer Clinical Research Unit

> **NIH NIH U01** · INDIANA UNIVERSITY INDIANAPOLIS · 2021 · $551,250

## Abstract

SUMMARY
We propose the establishment of a Clinical Research Unit (CRU) to participate in the planned Diabetic Foot
Consortium (DFC). The overall objective is to participate in multi-site clinical research to validate biomarkers
for diabetic foot ulcers (DFU). The Ohio State University Wexner Medical Center (OSUWMC) Comprehensive
Wound Center (CWC) was founded in 2005 with the mission to transform wound care delivery by developing
an interdisciplinary research and education program that would deliver cutting edge innovation and be
competitively funded extramurally. OSU is ideally suited to become the proposed consortium CRU because:
(1) the CWC is a high volume clinical enterprise that hosts one of the most productive wound healing research
programs in the country; (2) extraordinary institutional support has enabled CWC to host a sizeable chronic
wound (biopsy & fluid) tissue bank; (3) proven long-term track record of interdisciplinary partnership including
that with engineering that has resulted in novel non-invasive wound imaging and related platforms; (4)
leadership of OSU faculty in the community of wound healing care and research nationally; (5) competitive
track record in NIH/DoD funding in wound healing research; and (6) at present 22 OSU-based wound healing
trials ongoing with >2000 patients actively enrolled. We propose to leverage our local resources and expertise
to address the following three specific aims: §Aim 1. Provide wound healing expertise and an efficient clinical
and scientific infrastructure to develop evidentiary criteria for qualifying/validating the targeted DFU biomarker.
§1.1 CRU leaders with strong record of basic/clinical/translation research in wound healing. §1.2 Patient
populations with diabetic foot ulcers and their wound care at the institution §1.3 DFU-centric challenges
specific to DFU biomarker trial and potential solutions §1.4 Develop and implement novel strategies to monitor
and address the confounding factors relevant to biomarker study outcomes. §Aim 2. Identify, enroll and retain
patients with DFU. §2.1 Implementation of clinical research. §2.2 Use patient-centered strategies to recruit and
retain targeted DFU population across the health system enterprise. §2.3 Ensure efficient study start-up,
conduct and monitoring §2.4. Collect, store and ship DFU samples §2.5 Ensure the safety and rights of all trial
participants through efficient scheduling and completion of all study procedures and clinical center visits. §Aim
3. Establish CRU administration and achieve Diabetic Foot Consortium (DFC) readiness §3.1 Establish
leadership plan and functional areas of responsibilities. §3.2 Communications and fostering interactions. §3.3
Travel §3.4 Succession plan, cross-training and back-up personnel.

## Key facts

- **NIH application ID:** 10201585
- **Project number:** 5U01DK119099-04
- **Recipient organization:** INDIANA UNIVERSITY INDIANAPOLIS
- **Principal Investigator:** Gayle M Gordillo
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $551,250
- **Award type:** 5
- **Project period:** 2018-09-21 → 2022-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10201585

## Citation

> US National Institutes of Health, RePORTER application 10201585, Diabetic Foot Ulcer Clinical Research Unit (5U01DK119099-04). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10201585. Licensed CC0.

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