PROTEASE MODULATING WOUND DRESSINGS FOR THE TREATMENT OF VENOUS ULCERS

用于治疗静脉溃疡的蛋白酶调节伤口敷料

• 批准号: 6998556
• 负责人: DAVID J VACHON
• 金额: $ 19.66万
• 依托单位: AEGIS BIOSCIENCES, LLC
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-30 至 2008-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6998556
• 关键词: antiinflammatory agents; antiulcer drug; bioengineering /biomedical engineering; biomaterial development /preparation; biomaterial evaluation; biomaterial interface interaction; biopsy; clinical chemistry; clinical research; combination therapy; elastases; exudate /transudate; gel; human subject; leg; neutrophil; patient oriented research; polystyrenes; protease inhibitor; sulfonate; surface coating; tissue inhibitor of metalloproteinases; ulcer; wound healing

DESCRIPTION (provided by applicant): It is estimated that 2.5 million people in the United States have chronic venous ulcers. In the developed world, at least 0.1% of the adult population is likely to experience venous ulceration at some time. With the overall prevalence, estimated to be between 1.1 and 3.0 incidents per one thousand individuals, occurrence of venous ulcers increases exponentially with age reaching as high as 20 cases per thousand in the population over 80 years of age. Approximately 60-80% of chronic leg ulcers have an isolated or predominant venous component and 10-30% of cases are associated with arterial insufficiency. Venous ulcers develop slowly and often initiate with swelling. These wounds typically occur above the ankle and below the knee, along the lower medial 1/3rd of the leg (medial malleolus) and result largely from venous insufficiency. The major causes of venous insufficiency, potentially leading to non-healing stasis ulcers, include varicose veins, deep venous thrombosis, neoplastic obstructions, and congenital or acquired arterio-venous fistulae. People at higher risk of recurrence include those unable to wear compression stockings and it is known that recurrence rates are as frequent as 70% of all cases. Furthermore, venous ulcer disease is often complicated by cellulitis necessitating hospitalization or oral antibiotics. Available and current treatment regimens, in particularly compression therapy, debridement of necrotic tissue, treatment of edema, and control of infection are believed to reduce recurrence rates from 20-30%. Despite recent advances in wound dressings and compression bandages, venous ulcers remain clinically significant and difficult to manage. As such, the treatment for venous ulceration claims a significant portion of healthcare resources. While the current standard of care for venous ulcers provides benefit to many patients, a significant number of ulcers fail to heal and become chronic wounds. This poor success rate burdens society with monthly healthcare costs estimated at approximately $2400 for each venous leg ulcer. It has been estimated that the annual treatment costs in the United States for hard to heal wounds is approaching as much as $20 billion. As such, there has been a search for additional therapeutic compounds and/or devices to enhance ulcer healing beyond that provided by standard care. This proposal discloses a moist wound dressing that has the capacity Jo move moisture away from the wound, naturally sequester neutrophil elastase from the wound, and also add a low-dose metalloproteinase inhibitor (antibiotic) that will block some amount of these noxious wound factors known to impede healing, specifically neutrophil collagenase (MMP-8).

描述（由申请人提供）：据估计，美国有250万人患有慢性静脉溃疡。在发达国家中，至少有0.1％的成年人口可能在某个时候可能经历静脉溃疡。由于总体患病率估计在每千人中为1.1至3.0事件，静脉溃疡的发生呈指数增长，年龄在80岁以上的人口中的年龄高达20例。大约60-80％的慢性腿溃疡具有孤立或主要的静脉成分，10-30％的病例与动脉功能不全有关。静脉溃疡发育缓慢，并且经常随着肿胀而启动。这些伤口通常发生在脚踝上方，膝盖下方，沿着腿部下部1/3（内侧马利果），主要是由于静脉不足而导致的。静脉功能不全的主要原因，可能导致非愈合的停滞性溃疡，包括静脉曲张，深静脉血栓形成，肿瘤障碍物，肿瘤障碍物以及先天性或获得的动脉静脉瘘。复发风险较高的人包括那些无法佩戴压缩袜的人，众所周知，复发率与所有情况的70％一样常见。此外，需要住院或口服抗生素的纤维炎通常会使静脉溃疡疾病复杂化。可用的和当前的治疗方案，特别是压缩疗法，坏死组织的清创术，水肿的治疗以及对感染的控制可将复发率从20-30％降低。尽管伤口敷料和压缩绷带最近取得了进步，但静脉溃疡仍然具有临床意义且难以管理。因此，静脉溃疡的治疗占医疗资源的很大一部分。虽然目前对静脉溃疡的护理标准为许多患者提供了好处，但大量溃疡无法愈合并成为慢性伤口。这个成功率差的人为社会带来了每月的医疗保健费用，每个静脉腿溃疡约为2400美元。据估计，美国难以治愈的伤口的年度治疗费用接近200亿美元。因此，人们一直在寻找其他治疗化合物和/或设备，以增强溃疡的愈合，超出标准护理提供的溃疡。 该提议揭示了一种湿润的伤口敷料，其能力使乔从伤口移开水分，自然会从伤口中递出中性粒细胞弹性酶，还增加了低剂量的金属蛋白酶抑制剂（抗生素），该抑制剂（抗生素）会阻止一些已知的有害伤口因素，这些有害伤口因抑制了中性粒细胞胶原酶（MMMP-8）。