# Advancing Diabetic Foot Ulcer Treatment with Provasliex, a Controlled PDGF Release Hydrogel for Promoting Vascularization and Managing Overactive Inflammation

> **NIH NIH R43** · GELSANA THERAPEUTICS, INC. · 2024 · $324,992

## Abstract

Summary
GelSana is developing the Provasliex GelTM, a zwitterionic hydrogel that delivers controlled release of platelet
derived growth factor (PDGF) to address the need for better treatments for impaired wound healing associated
with diabetes. There are approximately 37 million people in the U.S. with diabetes and nearly 25% of patients
will suffer from diabetic foot ulcers (DFU) and lower leg ulcerations in their lifetime. Lower limb amputations
associated with impaired wound healing and lower leg ulceration are the primary reason for hospitalization of
patients with diabetes leading to 154,000 lower limb amputations per year in the U.S. The current standard of
care approach for treatment of diabetic wounds are to use standard gauze and antibacterial solutions to reduce
infection, but these approaches do not address underlying issues associated with inflammation of the wound.
Becaplermin (Regranex) is a topical gel that provides PDGF to the wound bed that has been shown to be safe
and can improve diabetic wound healing. Unfortunately, Regranex is limited clinically, as dressings must be
changed frequently, often 2x per day, as biologics like PDGF degrade fairly rapidly in the wound healing
environment and therefore must be consistently supplied to have a therapeutic impact. There is significant
potential for controlled release of PDGF over time to significantly improve the rate of wound healing and reduce
the frequency of dressing changes for patients. To address this need, GelSana has developed a zwitterionic
hydrogel that repels protein adsorption, prevents the foreign body response, reduces inflammation by modulating
macrophage state, and supports controlled release of PDGF. The Provasliex Gel (zwitterionic hydrogel + PDGF)
will have a multifactorial impact on wound healing as the hydrogel alone reduces inflammation in the wound bed,
protects PDGF from degradation, and enables consistent controlled release to promote wound healing. Prior to
this Phase I submission, GelSana has demonstrated controlled release of PDGF across several days, that the
zwitterionic hydrogel alone reduces healing time of wounds in a diabetic mouse model, and that the hydrogel
limits activation of an inflammatory macrophage phenotype. The goal of this project will be to demonstrate
feasibility towards improved wound healing with Provasliex Gel in mouse and pig models of diabetic wound
healing compared to Regranex. Commercialization of Provasliex Gel would significantly improve patient
morbidity outcomes through accelerated wound healing and would substantially improve patient quality of life by
reducing the frequency of painful dressing changes.

## Key facts

- **NIH application ID:** 11007010
- **Project number:** 1R43DK141293-01
- **Recipient organization:** GELSANA THERAPEUTICS, INC.
- **Principal Investigator:** Adam Rocker
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $324,992
- **Award type:** 1
- **Project period:** 2024-09-05 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11007010

## Citation

> US National Institutes of Health, RePORTER application 11007010, Advancing Diabetic Foot Ulcer Treatment with Provasliex, a Controlled PDGF Release Hydrogel for Promoting Vascularization and Managing Overactive Inflammation (1R43DK141293-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/11007010. Licensed CC0.

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