The Development and Testing of a Sonic Treatment Brush for Diabetic Foot Ulcers

DESCRIPTION (provided by applicant): Non-healing diabetic foot ulcers are potentially a limb- and life-threatening complication of chronic diabetes mellitus and associated peripheral neuropathy. Non-healing foot ulcers are the single most common reason for diabetic hospital admissions as well as the leading cause of non-traumatic lower extremity amputations performed in the U.S. Existing treatments for non-healing foot ulcers are obviously often ineffective. A new hand-held power cleaning brush with high frequency (sonic) bristle action has recently been developed for cosmetic skin care (Clarisonic(tm)). The further development and modification of this product into a sonic wound care device will provide two important functions: 1) Its sonic mechanical action will loosen and remove necrotic tissue, disrupt microbial biofilms and increase perfusion to the wound site. 2) The fluid forces it generate sex tend beyond its bristle tips and will flush the wound crevices, remove free-floating bacteria, increase aeration and increase penetration of medications into the wound. The specific aims of this proposal are: 1) To develop an optimized sonic wound care brush by modifying the existing Clarisonic(tm) power level and brush head design for diabetic wound treatment. This objective will be reached by successive redesigning of the brush (iterative prototypes) following medical professional evaluation of the modified brushes on actual human diabetic wounds. 2) To elicit quantitatively significant improvements in wound bed healing (i.e., reduction in the measured size of the ulcer, amount of exudates, type and color of wound tissue) over the standard of care as rated by two independent wound care specialists. 3) To reduce the bacterial burden on the wound bed surface compared to standard treatments of lavage saline irrigation and wet-to-dry saline moistened gauze dressings. The overall relevance of the proposed project is that existing treatments of diabetic foot ulcers are frequently ineffective, often leading to hospitalization and lower extremity amputations. The proposed sonic wound care device will be used by wound therapists to improve healing of foot ulcers and reduce the risk of infection and amputation. Unlike conventional power skin brushes, the sonic wound care brushuses novel, patentable technology for oscillating the brush head at over 340 movements per second. The high-speed brush movement is driven by innovative, proprietary electronic microprocessor technology. The sonic wound care brush will be relatively low cost and will provide efficient and effective augmentation of existing therapy for diabetic foot ulcers. The public health relevance of this project is to develop a new, more effective device to treat non-healing diabetic foot ulcers. The primary goal of this novel device is to speed healing of diabetic foot ulcers and thereby prevent lower extremity amputations, which too often are needed using the existing, traditional treatment methods.