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.
The overall goal of this project is to develop an effective product for chronic wounds of the lower extremity, including diabetic foot ulcers and venous leg ulcers. The basic technology is zeolites that contain nitric oxide (NO), an agent that has proven effective in treating chronic wounds. However, since NO is a gas, NO delivery to the desired area is difficult. A product that can control the release of NO during the various phases of wound healing would be an important solution for enhanced healing of chronic wounds. The outcomes of this research were: (a) Controllable release of nitric oxide from a topical wound treatment based on nitric oxide loaded zeolites, (b) Acceleration of wound healing in vivo using two different animal models: ischemic rabbit ears and obese rats, and (c) Achievement of therapeutically relevant levels of NO release during wound healing in both animal models. In this Phase I research, we achieved controllable rate of nitric oxide release by varying the composition of hydrogels and ointments mixed with NO-zeolite. NO-zeolites release nitric oxide when they come in contact with water or wound fluid. By controlling the rate at which water becomes available to NO-zeolites in a wound dressing, it was possible to control the rate of nitric oxide release into the wound. Our results provide proof of concept of ways to control NO release by incorporating NO-loaded zeolites into selected delivery vehicles. Our project further provided evidence that NO-zeolite wound dressings significantly accelerate the wound healing process in animal wounds. This finding was established by conducting acute wound experiments on obese rats and ischemic wound experiments on rabbit ears. In both animal studies, wounds treated with NO-zeolite wound dressing healed faster than control wounds. These results demonstrate that therapeutic levels of nitric oxide delivery can be attained using NO-zeolite wound dressings. 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.
