SBIR Phase I: Microneedle Bandage for Diabetic Foot Ulcers

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is an advanced wound care product that speeds healing of diabetic foot ulcers. These ulcers afflict millions of Americans, causing pain, loss of mobility, amputations, and potentially life-threatening infections. The average annual expenditure for diabetic foot care is $8,659 per patient resulting in cumulative costs of $9 to $13 billion in the United States alone.

Foot ulceration often progresses to chronic infection, osteitis, and severe gangrene, resulting in over 100,000 amputations per year. The patented microneedle technology to be developed has significant commercial potential as a low-cost alternative for treating stalled wounds. By rapidly clearing the infections that block proper wound healing, the product will garner significant market share based on its ability to speed healing.

The initial target market will generate approximately $4.2 M per year and is expected to accelerate rapidly when implemented nationwide. This will further increase as the product is adopted into adjacent markets.

This Small Business Innovation Research (SBIR) Phase I project will develop an advanced wound care product that disinfects diabetic foot ulcers using a patented microneedle patch design that delivers three potent therapeutic agents, each of which participates in different aspects of wound healing. These agents are time-released to further enhance their function.

Once the microneedle patch is applied to a recently debrided diabetic foot ulcer, a powerful antibiotic will be released to establish a bacterial killing zone in the dermal tissue of the wound. A second agent will prevent the re-formation of a bacterial biofilm, and a third agent known as a chemokine will attract and activate white blood cells to rapidly clean-up the infected area and kill any residual bacteria.

Once the microneedle tips dissolve, a channel will open which facilitates wound drainage. Initial work will be performed using skin tissue cultures, followed by testing using diabetic pigs. The microneedles are expected to kill the bacteria including methicillin-resistant Staphylococcus aureus (MRSA).

It will also prevent any surviving bacteria from forming biofilms, and mop-up any remaining bacteria by activating the innate immune system. Once these wounds have been disinfected the wound will resume normal healing over the ensuing weeks.

This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.