SBIR-STTR Award

There is an immense need for developing clinically effective treatments of chronic wounds. Estimates of the costs for treating chronic wounds range into the billions of dollars annually. As Western society continues to age, the problem of chronic wounds will likely increase. Recent studies indicate proteases released during an over exuberant neutrophil response may have a significant role in the pathophysiology of chronic wounds. The objective of this proposed study is to test the feasibility of designing and developing dressings with the ability to sequestered/inhibit neutrophil derived proteases. Focus will be on the utilization of modified cellulosic-based materials. Cellulosic-based materials will be modified so as to introduce functional modalities that are predicted to bind neutrophil elastase and possibly other cationic neutrophil-derived proteases. In vitro assays will be used to assess the ability of several modified products to remove proteolytic activities from wound fluids. Candidate materials with desired sequestering properties will e further examined for pH stability, sterilization stability, and cytotoxicity. Besides their basis on a rational strategy, such a modified cellulosic-based material will have the additional advantage of being relatively inexpensive and thus have a high potential for use in the world-wide market. Once the principle has proved on a simple cellulosic dressing material, experiments will be conducted to expand the potential for other more sophisticated substrates for use as dressing materials (patents pending) and expanding the range of sequestering/inhibiting compounds onto the dressing or in the form of an ointment cream lotion. PROPOSED COMMERCIAL APPLICATIONS: The total cost for treating chronic wound sis estimated at $22-26 bn (Page 11), the cost of dressings used is in excess of $1 bn (Page 13). When compared with both currently available wound care products and those in development the technology has the following significant advantage: non invasive method of treatment; low cost of manufacture; potential to enter the 3rd world markets and bring affordable health care to this normally overlooked segment of the population; comparable clinical performance to the pharmaceutical growth factors that are priced at $300 per tube. This unique set of factors combine to offer a sales potential estimated at $95MM in the US and triple that number worldwide.

Thesaurus Terms:
cellulose, cotton, elastase, technology /technique development, wound, wound healing decubitus ulcer, protease inhibitor, wound infection clinical research, human subject

The objective of this proposal is to develop an inexpensive but sophisticated and effective dressing for chronic wound treatment. Elastase destroys growth factors in the wound as well as their receptors. MMPs destroy matrix within the wound. Therefore, by reducing these factors in the wound, there will be reduced destruction of cytokines and their receptors as well as a reduction in collagen matrix breakdown This is our first dressing planned for clinical use. Others are in development. Having competed the tasks of Phase I, Phase II will include the following SPECIFIC AIMS : (1) DAG DRESSING PREPARATION: for use in human pressure ulcers under FDA GLP/GMP device guidelines at our USDA facility. (2) CLINICAL EFFECTIVENESS: this dressing will be used in the pressure ulcers of 30 patients (10 pts per dressing group) under appropriate exclusion and inclusion criteria. Protease activity (MMP-8 and elastase) will be measured in wound fluid and wound biopsies before dressings are applied and at the termination of the study. Dressings will be changed daily and dressings saved for protease quantitation. Wound volume will be determined with geltrate molds each week. Each patient will serve as his or her own control using a moist saline gauze treatment period and there will be a gauze control. (3) PRODUCTION OF DRESSING FOR PRODUCT FOR CLINICAL MARKET Dressings will be produced for the clinical studies at our USDA facilities. Members if the TT team in Richmond and New Orleans and DeRoyal have, and will continue to meet to solve any problems that occur during the development phase. DeRoyal has extensive experience with the FDA in bringing wound dressing devices to the market and will be very active in helping with these actions.

Thesaurus Terms:
biomaterial development /preparation, cellulose, cotton, elastase, human therapy evaluation, wound, wound healing clinical trial, decubitus ulcer, growth factor, protease inhibitor, wound infection biopsy, clinical research, human subject, patient oriented research