# Diabetic Foot Ulcer Biofilm Infection and Recurrence

> **NIH NIH R01** · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · 2024 · $567,468

## Abstract

Abstract
Diabetic foot ulcers (DFU) are one of the most common reason for hospitalization of diabetic patients and
frequently it results in amputation of lower limbs. Of the one million people who undergo non-traumatic leg
amputations annually worldwide, 75% are performed on people who have type 2 diabetes (T2DM). The risk of
death at 10 years for a diabetic with DFU is twice as high as the risk for a patient without a DFU. The rate of
amputation in patients with DFU is 38.4%. Infection is a common (>50%) complication of DFU. In those with
DFU, 40% recur within one year after wound closure; 60% within 3 years, and 65% within 5 years. Thus, the
strongest predictor of DFU is a previous foot ulcer. The proposed work rests on a series of pre-clinical and
clinical findings laying the foundation to the hypothesis that biofilm infection of DFU compromises barrier
function of the closed DFU. Such deficient closure paves the way to DFU recurrence. Biofilms are estimated to
account for 60% of chronic wound infections. In the biofilm form, bacteria are in a dormant metabolic state. The
standard clinical techniques like colony forming units (CFU) assay to detect infection may not detect biofilm
infection. Thus, biofilm infection may be viewed as a silent maleficent threat in wound care. The proposed work
is a two-center study – Indiana University and Stanford University – who were competitively funded with a pilot
award by the NIDDK-DIACOMP mechanism to generate preliminary data on DFU closure and recurrence. The
proposed work addresses a novel paradigm in DFU care that has never been tested in a fully powered patient-
based study. Successful execution of the proposed work is likely to have direct impact on the current standards
of wound care including re-defining the most important primary endpoint of wound care, wound closure itself.
For the first time in a DFU patient-based study, mechanisms by which biofilm infection induces molecular
mechanisms that compromise functional integrity of re-epithelialized DFU will be elucidated. In DFU care, the
proposed work may identify that the current endpoint of wound closure (that does not account for any
functional parameter) may be not the right time to stop caring for DFU. That such premature termination of
care may be responsible for the high recurrence of DFU that is currently reported. The notion that continued
care, until functional wound closure is achieved, is necessary to minimize recurrence and amputation would be
of transformative value in the delivery of DFU care. This proposal, wholly based on the study of DFU patients
seeks to conduct a two-centered robust clinical study testing whether wounds with a history of biofilm infection
closes with deficient barrier function (Aim 2). Aim 3 tests whether such deficient wound closure which
manifests as high TEWL is associated with greater wound recurrence. Aim 1 utilizes this patient-based study to
address molecular mechanisms implicated in biofilm-induced loss o...

## Key facts

- **NIH application ID:** 10854979
- **Project number:** 5R01DK125835-06
- **Recipient organization:** UNIVERSITY OF PITTSBURGH AT PITTSBURGH
- **Principal Investigator:** GEOFFREY C GURTNER
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $567,468
- **Award type:** 5
- **Project period:** 2020-09-07 → 2027-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10854979

## Citation

> US National Institutes of Health, RePORTER application 10854979, Diabetic Foot Ulcer Biofilm Infection and Recurrence (5R01DK125835-06). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10854979. Licensed CC0.

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