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

这个小企业创新研究（SBIR）第一阶段项目是关于开发一种有效的产品，用于下肢慢性伤口;糖尿病足溃疡和静脉性腿部溃疡。基本技术是含有一氧化氮的沸石，一氧化氮是一种已被证明对治疗慢性伤口有效的药剂。然而，由于NO是气体，因此将NO输送到所需区域是困难的。设计用于在伤口愈合的各个阶段维持最佳NO水平的新产品将是促进慢性伤口愈合的重要解决方案。该项目有两个目的：a）证明含有NO的沸石在改善慢性伤口愈合中的功效。这将在伤口愈合受损的动物模型中实现，使用非侵入性光学器件来监测伤口愈合，以及B）开发一种水凝胶，其实现NO向组织的受控释放。这项研究的更广泛/商业影响是显著的：如果成功，所开发的产品可以减少与治疗糖尿病足溃疡和相关截肢相关的估计每年超过100亿美元的美国医疗保健成本。此外，约320万受腿部溃疡影响的美国人将获得有效治疗。这些溃疡的复发率高达70%，估计每年的费用为35亿美元。开发一种具有成本效益且可在任何护理或伤口护理机构作为敷料施用的商业产品将对患者的生活质量和降低医疗保健成本产生改变生活的影响。

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.