SBIR-STTR Award

Chronic wounds are a major health care problem, consuming over $10 billion annually in treatment costs. We will perform a feasibility study into the synergistic effects of combining ultrasound insonation and Collagen treatments, based on the knowledge of their independent action in accelerating and assisting the wound healing process. The experimental approach will use a carefully designed and calibrated ultrasound exposure system. Full thickness wounds of 1.5 cm in diameter will be used in an adult pig model, with an experimental duration of 21 days from initial injury to final assay. The protocol will involve three different groups: (1) a collagen bead suspension treatment, (2) the application of Duoderm (hydrocolloid dressing), and (3) a non-reacting solution (isotonic buffered saline). Each group will have a corresponding control not subjected to ultrasound exposure (six groups total). Each of six pigs will have nine wound sites, with daily ultrasound exposure for five minutes per day, and repeat collagen application daily until fully granulated. Wound analysis will include: wound size measurement, extent of granulation, water vapor transmission, and histological studies on 7, 14 and 21 postinjury. If successful, this research will open up a new cost-effective avenue of sound wound management.Awardee's statement of the potential commercial applications of the research:If successful, the combination treatment would result in dramatic reductions in health care costs in the $10 billion wound care market. This is because the component treatment modalities-ultrasound and collagen application-are relatively low cost. The combination treatment lends itself to non-hospital settings, such as outpatient clinics, aged and nonambulatory care facilities, and potentially even the home, assuring significant market penetration.National Institute on Aging (NIA)

Wounds, especially chronic wounds, continue to challenge health care professionals, consuming over $10 billion annual in treatment costs. We will continue our successful Phase I effort to examine the beneficial effects of combining ultrasound insonation and collagen treatments. Phase I demonstrated the feasibility of this approach with improvements in wound tensile strength, toughness, and histological appearance when ultrasound was applied to 1.5 cm full thickness wounds in an adult Yucatan pig model. The current work is aimed at pre-clinical evaluation of different ultrasound exposure regimes, varying frequency (0.75 and 1.5 MHz), and intensity (100, 200, and 500 mW/cm2 I-sata) with daily treatments of 5 minutes a day. In order to have statistically significant results, 12 wound sites on each of 5 pigs will be tested at a time, with an experimental duration of 28 days (from initial wounding to final assays); there will be 12 such groups over the two year extent of the program. Wound analysis will include visual wound assessment with photographic recording, transepidermal water loss, laser Doppler blood flowmetry, cyclic and ultimate mechanical property testing, histopathology, and collagen analysis. This research will lay the groundwork for further clinical development under Phase III.National Institute on Aging (NIA)