Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R43GM075581-01
Agency Tracking Number: GM075581
Amount: $196,569.00
Phase: Phase I
Program: SBIR
Awards Year: 2006
Solicitation Year: 2006
Solicitation Topic Code: N/A
Solicitation Number: PHS2006-2
Small Business Information
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (509) 210-0736
Business Contact
Phone: (509) 210-0736
Research Institution
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 one third 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).

* Information listed above is at the time of submission. *

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