# Diabetic Foot Consortium Clinical Research Unit

> **NIH NIH U01** · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · 2024 · $781,757

## Abstract

SUMMARY
We propose the continuation of an established Clinical Research Unit (CRU) towards the success of an
established NIDDK-sponsored Diabetic Foot Consortium (DFC). The overall objective of the CRU, established
during the previous cycle, was to participate in multi-site clinical research to validate biomarkers for diabetic foot
ulcer (DFU) care. Six CRU were funded in cycle 1 (DFC1.0), including IU, of which, four remain as active sites for
the ongoing DFC studies. This CRU is high performing per objective metrices presented. This CRU is also a
competitively awarded Biomarker Analysis Unit (BAU) – home to the TEWL (Trans-Epidermal Water Loss) study.
The TEWL study enrolled the first DFC subject on June 17, 2020, at this CRU. This proposal to renew the IN
CRU is aimed at maintaining and exceeding our performance during DFC1.0 which was limited by the pandemic.
We are currently the only site with an active CRU, Biomarker Analysis Unit (BAU) and R61/R33- all of which
have been independently competitively awarded as part of the DFC. During DFC1.0, IU introduced the inclusion
of two local satellite sites within the IU infrastructure as a pilot effort to gauge the impact on patient recruitment
and sustainability of managing multiple sites. With supplemental funding support from the DFC, these sites
added to the overall productivity of the IU CRU and led to the addition of a third site (Podiatry Associates, IN)
outside the IU infrastructure. For cycle 2 (DFC2.0), we will continue to leverage our local resources and expertise
and build new satellite network connections to address the following three specific aims: Aim 1. Provide
continued wound healing expertise and an efficient clinical and scientific infrastructure to develop evidentiary
criteria for qualifying/validating the targeted Diabetic Foot Ulcer (DFU) biomarkers. 1.1 CRU leaders with strong
record of basic/clinical/translation research in wound healing. 1.2 Patient populations with DFU, current and
further advancement of local Standards of Care. 1.3 Evaluate impact of Social Determinants of Health (SDH) for
DFU healing and recurrence. 1.4 Leadership and implementation of the Satellite Pilot Program (SPP). Aim 2.
Identify, enroll, and retain patients with DFU. 2.1 Subject identification and enrollment. 2.2 Use patient-centered
strategies to recruit and retain targeted DFU patients. 2.3 Ensure timely completion of current cycle protocols
(TEWL and c-Myc). 2.4 Ensure efficient conduct and monitoring of ongoing biorepository protocol. 2.5 Ensure
efficient study protocol start-up, conduct and monitoring of new R61/33 ancillary protocols. 2.6 Collect, store
and ship DFU biosamples. 2.7 Ensure the safety and rights of all trial participants through efficient scheduling
and completion of all study procedures and clinical center visits. Aim 3. Support established CRU administration
to achieve continued Diabetic Foot Consortium (DFC) readiness 3.1 Support established leadership plan and
functional a...

## Key facts

- **NIH application ID:** 10804694
- **Project number:** 5U01DK119099-08
- **Recipient organization:** UNIVERSITY OF PITTSBURGH AT PITTSBURGH
- **Principal Investigator:** Gayle M Gordillo
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $781,757
- **Award type:** 5
- **Project period:** 2018-09-21 → 2027-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10804694

## Citation

> US National Institutes of Health, RePORTER application 10804694, Diabetic Foot Consortium Clinical Research Unit (5U01DK119099-08). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10804694. Licensed CC0.

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