Use of Droplette Micromist Technology Device (DMTD) for Deep Tissue Treatment of Pressure Ulcers
Abstract
This project addresses the Fiscal Year 2022 (FY22) Peer Reviewed Medical Research Program (PRMRP) Portfolio Internal Medicine and the Topic Area Pressure Ulcers. The FY22 PRMRP Strategic Goal addressed here is Develop and test novel treatments, and/or improve upon existing treatments for associated diseases and conditions. The overarching goal of this project is to develop a new deep tissue treatment for non-healing Stage 3 and Stage 4 pressure ulcers (PUs) that often lead to limb amputations and cause extreme pain. PUs affect 2.5 million people per year and costs $2.6 billion. In Veterans Affairs (VA) hospitals, the incidence rate of PU is almost double that of national average. The fact that 53% of active-duty military casualties in Operation Iraqi Freedom had pressure injuries and there is a 22% incidence rate of PU across most military medicinal facilities, underscores the increased risk for PUs in active-duty military personnel. PU treatment is one of the most challenging clinical problems in hospitals across the world, especially among patients with spinal cord injury, elderly patients, immune compromised patients, and in patients with metabolic diseases such as diabetes. Clinical studies show that recurrence of PUs occurs at a high rate (11% to 29% in cases with postoperative complications and 6% to 61% in cases without postoperative complications). This is due to the incomplete healing of deep tissues that are damaged at the site of pressure ulcer due to lack of availability of molecules that stimulate deep tissue repair. Currently, there are no effective treatments to completely heal damaged deep tissues and prevent recurrence of pressure ulcers. PUs and pressure injuries are caused by localized damage to the skin and/or underlying tissue from direct pressure, or pressure in combination with shear. PUs usually develop over a bony prominence, but can also develop in skin areas under constant pressure load from medical devices or environmental conditions that cause deformation of skin and deeper tissues near the contact region. Such constant external pressure induces deep tissue ischemia, cell death, inflammation and edema, and tissue necrosis resulting in PUs. Proper debridement and offloading are essential, but not sufficient to heal chronic PUs such as those in pathology Stages 3 and 4. Current PU treatments use skin substitutes (natural or artificial) placed on top of the wounds. Skin substitutes can carry stem cells that can differentiate into epithelial cells, and collagens and growth factors to promote wound closure from the top of the wound. However, as pointed out in the 2020 Technical Brief (Project ID: WNDT0818) of the U.S. Department of Health and Human Services, none of the clinical trials with skin substitutes show that they prevent recurrence of PUs. Thus, there is a desperate medical need for new treatments to completely heal damaged deep tissues, particularly in Stage 3 and Stage 4 PUs and prevent PU recurrence. The lack of efficient methods of delivery for growth factors, cytokines, and reparative gene or protein therapy to the deep wound beds of PUs impedes development of effective treatments to reduce the high rates of PU recurrence. To overcome this issue, we propose to use our custom made Droplette Micromist Technology Device (DMTD), a hand-held, needle-free, transdermal delivery device that generates a micromist that can package and deliver high molecular weight biologics through intact skin. DMTD is a patented product of Droplette Inc., Boston, Massachusetts, custom-made for the proposed studies. Our published studies show that DMTD-delivered high molecular weight antibiotics on the skin could successfully attenuate E. coli infection as deep as ~6mm in the skin of a rat model. Our recent studies show that DMTD-delivered plasmid DNA expressed new proteins in skin cells located at a depth of ~5mm from skin surface in pig and rat models. Inflammatory immune cells suc
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Jan 04, 2024
- Source ID
- HT94252310524
Entities
People
- Lakshmidevi Pulakat
Organizations
- Tufts Medical Center
- United States Army