Wounds, especially chronic wounds, continue to challenge health care professionals, consuming over $10 billion annually in treatment costs. We are proposing to continue our successful Phase I effort to examine the beneficial effects of combining ultrasound insonation and collagen treatments. Phase 1 demonstrated the feasibility of the 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.
The Phase II studies will form the basis of future commercialization efforts, using a model well understood by the wound treatment community. The combination treatment proposed here could have a significant impact upon this market, with a dramatic reduction in healthcare costs. 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 non-ambulatory care facilities, and potentially even the home, assuring significant market penetration.
