Development of a novel device for diabetic wound healing using high-frequency, low amplitude vibration - Project Summary Diabetic foot ulcers (DFU) pose a considerable healthcare burden, impacting a large population and incurring substantial Medicare expenses. Given the limited array of available treatments, there is a clear demand for innovative approaches. Existing methods for DFU management, although diverse, frequently do not augment blood flow, a vital element in the wound healing process. In the short term, our objective is to utilize HFLAV to determine the healing time of stage 2 DFUs and evaluate their impact on quality of life (QOL) when compared to conventional standard of care approaches. Our long- term vision is to refine HFLAV protocols for application across a broad spectrum of diabetic wounds, regardless of associated comorbidities, and enhance the physical well-being of diabetic patients. Our central hypothesis posits HFLAV has the potential to reduce the time required for stage 2 DFUs to heal by as much as 30% while concurrently enhancing QOL scores. This hypothesis draws upon a comprehensive understanding of vascular endothelial physiology and previously published research findings. The underlying rationale is that expediting the healing process of stage 2 DFUs can serve as a foundation for addressing diabetic wounds comprehensively and alleviating the economic burden associated with wound care. Our research will revolve around two main objectives: (1) Enhance and validate the Driver device by incorporating thermography to measure blood flow and tissue heat depth. Ensure it meets ISO safety standards for Phase I-II development; and (2) Conduct a small R01 clinical trial to evaluate the safety and efficacy of the Driver device in diabetic ulcer patients. These aims collectively aim to improve diabetic wound healing and enhance the overall well-being of diabetic individuals. The proposed research is significant because accelerating stage 2 DFU healing could potentially save up to $2000 per month in outpatient healthcare costs, offering significant financial relief, considering the large diabetic population and ulcer prevalence. Additionally, the significance of this study for patients lies in the potential to offer a more efficient, less painful, and cost-effective approach to healing diabetic foot ulcers, ultimately improving the lives of those affected by this condition. The outcomes will have an important impact because of its potential to significantly improve the management and treatment of diabetic foot ulcers. This research serves as a foundational step in advancing the treatment of diabetic wounds, offering opportunities for further investigation, optimization, and the development of patient-centered approaches to wound management. It paves the way for future studies and innovations aimed at improving the health and well-being of individuals with diabetic foot ulcers and other diabetic wounds.
