Diabetes often causes poor circulation and nerve damage, meaning the patient may not feel or notice a wound or sore before it becomes large and severely infected.
This issue is compounded by the disease's impact on the immune system, inhibiting the body's ability to heal. These ulcers can lead to chronic infection, amputation and in some cases death. Despite the scale of the problem, effective treatment has frustrated patients, doctors and researchers for decades.
In a promising leap forward, a Tufts Medical Center investigator's innovative research shows there may be a quick, easy and incredibly effective solution to this unsolved problem. There is currently no way to provide gene therapy to damaged cells deep in the tissue. Injections can't be delivered deep into an infected wound, and even if this was an option, there is no guarantee the therapy would reach the appropriate cells. That's why Lakshmi Pulakat, PhD, Professor of Medicine and a researcher in the Molecular Cardiology Research Institute (MCRI) at Tufts Medical Center, launched an innovative collaboration with Droplette, a Boston-based skincare technology company that produces a device that delivers a micromist through intact skin, with no needles and no pain.
Dr. Pulakat asked Droplette to create a custom-made device to deliver antibiotics, proteins and DNA locally to suppress infection and improve healing. Dr. Pulakat's early studies have shown that the Droplette Micromist Technology Device (DMTD), specifically designed to achieve deeper penetration into skin and tissue and deliver the micromist therapy to a targeted wound as deep as 6 millimeters below the skin's surface, can revive damaged cells, stop inflammation, promote healing and prevent infection. Additionally, the device dispenses pre-metered doses in single-use capsules, ensuring precise dosing.
"We believe that the DMTD is a safe, painless and effective approach to deliver reparative gene and protein therapy deep into the tissue, and reach and repair damaged skin, muscle and bone cells to expedite healing and prevent limb amputations," said Dr. Pulakat. "The whole process is simple and needle- and pain-free. It doesn't cause the potential organ-damaging side effects of oral and intravenous antibiotics, and the device is hand-held, lightweight, portable and easy-to-use. This is really a huge breakthrough and a significant advance in DNA and protein therapy."
Dr. Pulakat's research secured a $3.2 million Technology and Therapeutic Development Award over four years from the Department of Defense to conduct a preclinical study to demonstrate that wound healing molecules delivered through the DMTD will help heal pressure ulcer wounds in animal models. Pulakat's collaborators on this study are Drs. Howard Chen and Payam Salehi (Tufts Medical Center) and Jonathan Garlick (Tufts University School of Dental Medicine). Additionally, Dr. Pulakat is working on a second project with researchers at the University of Missouri to use the DMTD to provide localized treatment for chronic wounds infected by multidrug resistant bacteria. This research was recently awarded a $1.2 million grant from the U.S. Army. If these studies show safety and efficacy in treating affected bone, muscle, skin and nerves – no matter how deep the damage – the next step will be clinical trials in humans.
