SBIR Phase I: Controlled Topical Delivery of Nitric Oxide for Wound Healing and Efficacy Assessment by Optical Monitoring

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This Small Business Innovation Research (SBIR) Phase I project is about developing an effective product for chronic wounds of the lower extremity; diabetic foot ulcers and venous leg ulcers. The basic technology is zeolites that contain nitric oxide, an agent that has proven effective in treating chronic wounds. However, since NO is a gas, NO delivery to the desired area is difficult. New products designed to maintain optimal levels of NO during the various phases of wound healing would be important solutions for enhanced healing of chronic wound. This project has two aims: a) prove efficacy of zeolites containing NO in improving healing in chronic wounds. This will be accomplished in animal models of impaired wound healing using non-invasive optics to monitor wound healing and b) develop a hydrogel that achieves controlled release of NO to the tissue.The broader/commercial impacts of this research are significant: if successful, the product developed could reduce the estimated US healthcare costs of more than $10 billion annually associated with treating diabetic foot ulcers and related amputations. Furthermore, approximately 3.2 million Americans who are affected by leg ulcers would be provided with effective treatment. Recurrence rate of these ulcers is as high as 70% and the annual cost is estimated to be $3.5billion. Developing a commercial product that is cost effective and can be administered at any nursing care or wound care facility as a dressing will have a life altering impact on the quality of life for the patients and in reducing healthcare costs.