# Developing biomarkers of healing and non-healing VLUs

> **NIH NIH R21** · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · 2023 · $371,470

## Abstract

Project Summary
This project proposes to use wound fluid analyses captured from discarded wound dressings to develop
biomarkers that can predict healing outcome and monitor healing progression of Venous Leg Ulcers (VLUs).
VLUs represent a specific case of chronic ulcers occurring in the gaiter area in the setting of chronic venous
insufficiency and account for about 70% of all chronic leg ulcers. Considering the aging of the population a
concerning picture emerges: more ulcers occurring in sicker patients which are ever more expensive to treat.
Despite recent advances, more than 50% of patients with VLUs fail to heal with standard care. One of the major
obstacles to improving outcomes is the inability to predict early on who will and who will not respond to standard
of care. Therefore, there is an urgent and unmet need to predict healing outcomes and to differentiate healing
from non-healing VLUs. Due to dynamic molecular changes within the wound, its microenvironment can be
tested and monitored, which offers an opportunity to obtain key information regarding the status of wound
biology. Moreover, quantification of such molecular changes that reflect wound healing status would provide
important tools that can guide treatment approach, directly impacting the clinical outcomes. Thus, both predictive
and monitoring biomarkers are needed to enable prospective tailoring of therapies to efficiently: 1) maximize the
treatment outcomes, 2) target more aggressive treatment to only those patients who need it and 3) develop
personalized approaches to each VLU. In the initial discovery phase, we will enroll 30 VLU patients (10 healers
and 20 non-healers) to identify a set of protein biomarkers that predict healing outcomes (Aim 1); those that can
serve as monitoring biomarkers (Aim 2). We will extract wound fluid from discarded wound dressings and quantify
proteins by using mass spectrometry (LC-MS/MS) and correlate them to healing outcomes at week 4. We have
generated preliminary data that support feasibility of the overall approach and confirm that wound dressings
(either analyzed in real time or stored frozen) of any type can be utilized for biomarker quantification. We have
also identified spatially distinct localization of molecules at the center vs perimeter of the wound dressing,
resulting in specific profiles that reflect the biology of the wound bed and wound edge respectively. This project
will provide a unique opportunity to capitalize on easy access of discarded wound dressings as a source of
wound biomaterial (exudate) that can serve for biomarker detection. It will not only identify and validate specific
set of biomarkers that can predict healing outcome and/or monitor healing progression but will also provide
streamlined method of detection that can be readily implemented.

## Key facts

- **NIH application ID:** 10786898
- **Project number:** 1R21AR083526-01
- **Recipient organization:** UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
- **Principal Investigator:** Ivan Jozic
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $371,470
- **Award type:** 1
- **Project period:** 2023-09-18 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10786898

## Citation

> US National Institutes of Health, RePORTER application 10786898, Developing biomarkers of healing and non-healing VLUs (1R21AR083526-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10786898. Licensed CC0.

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