# Developing strategies for effective debridement in patients for venous leg ulcers

> **NIH NIH R01** · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · 2020 · $530,649

## Abstract

Project Summary
The goal of this research is to use gene and protein expression patterns to develop point of care diagnostic
tool that can serve as a guiding tool to optimize debridement for non-healing venous leg ulcers (VLUs).
Thus, it will identify objective and reliable biomarkers that will guide wound practitioners to make informed
decision when wound edge debridement is adequate. We have shown that biopsies obtained from the non-
healing edges of VLUs before/after debridement have distinct morphologies and distinguishable gene and
protein expression patterns. Cells generated from pre-debridement edge biopsies exhibit a non-healing
phenotype as evidenced by loss of migration and loss of ability to respond to growth factors, suggesting a loss
of healing potential whereas cells genrated from post-debridement biopsy are migratiory and responsive to
growth factors. Some clinical data show a positive response in VLUs wound size reduction following wound
bed debridemet. However, wound bed debridement is not always considered standard of care for VLUs.
Therefore we aim to compare effectivnes of two therapeutic approaches: standard of care (i.e. compression
therapy) and wound bed debridement coupled to standard of care. The intervention arm will consit of two
subgroups, a) one that utilizes gene/protein expression-guidaded debridement protocol, and b) uses standard
clinical debridement protocol for VLUs. We hypothesize that gene/protein expression patterns can be utilized
to guide wound edge debridement in VLUs and further that such biomarker-guided debridement will improve
healing outcome in patients suffering from chronic non-healing VLUs. Also, based on genomic profiles we plan
to develop specific PCR- and immunostain-based methods to serve as a simplified diagnostic test to guide the
extent of debridment. Thus, we will conduct a randomized clinical trial to test if gene expression patterns can
be utilized as a guiding tool for the debridement extent and to test the effect of wound edge debridement on
healing progression (Aim 1) and develop PCR- and/or immunostain-based complementary assessment
method and validate it for guiding surgical debridement (Aim 2). We will proceed with genomic profiling and
compare gene expression patterns of specimens obtained before and after debridement. Next, expression
patterns will be correlated with healing outcomes comparing patients with wounds that progressed to healing
with those that did not at 4 weeks post intervention. The proposed study is the first step in incorporating
gene/protein wound signatures as a clinical tool. Successful completion of this study will provide objective
biological markers to guide wound edge debridement in patients suffering from VLUs. Incorporation of
molecular tools into armory of intervention will result in a paradigm shift that will alter the course of healing,
decrease morbidity, mortality, and lower associated treatment costs.

## Key facts

- **NIH application ID:** 9772256
- **Project number:** 5R01AR073614-02
- **Recipient organization:** UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
- **Principal Investigator:** Robert Scott Kirsner
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $530,649
- **Award type:** 5
- **Project period:** 2018-09-01 → 2023-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9772256

## Citation

> US National Institutes of Health, RePORTER application 9772256, Developing strategies for effective debridement in patients for venous leg ulcers (5R01AR073614-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9772256. Licensed CC0.

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