Acute and chronic wounds such as diabetic foot ulcers represent a major area of medical concern. With roughly 27 million patients suffering from these types of partial thickness wounds, representing substantial billions in medical expenses, a means to rapidly close such acute and chronic wounds with minimal medical staff involvement would be a major new breakthrough, capable of sustaining extremely high impact in the field. This proposed Phase I STTR effort which involves a collaborative partnership between Lynntech, Inc. and Beth Israel Deaconess Foot Center at Harvard Medical is specifically designed to address the above challenge. In this effort, we propose a new wound dressing technology, consisting of a contractile biocompatible hydrogel which may form adhesive bonds at the molecular level with cells in the wound bed. The hydrogel dressing will be engineered to de-swell upon application to the wound resulting in an applied contractile force felt throughout the wound bed. As the hydrogel contracts, it will stretch the wound edges inwards to stimulate primary wound closure. The hydrogel dressing will also contain biodegradable crosslinking to not only ensure that the average contractile force felt at the wound edges stays dominant even when the wound contracts over time but to also allow the dressing to be naturally excluded due to cell turnover towards the latter stages of healing. Since wound healing is impaired in the diabetic patients, including the primary wound contraction mechanisms responsible for natural wound closure;we hypothesize that this type of wound dressing technology should provide the greatest benefit to the healing of such chronic wounds. During this Phase I STTR effort, our overall goal is to provide proof-of-concept for the feasibility of this wound dressing by pursuing the following specific aims, namely (1) prepare and characterize contractile hydrogels, (2) optimize the contractile properties of the hydrogel, (3) optimize the biodegradability of the hydrogel, (4) perform ex-vivo cytotoxicity evaluation to demonstrate the biocompatible nature of the hydrogels, (5) perform preliminary animal studies utilizing normal and diabetic rabbit and murine models to demonstrate that the hydrogels are useful to accelerate wound closure. The successful completion of these specific aims should demonstrate ample feasibility of this new wound dressing technology, and will allow us to plan more comprehensive technology development and commercialization thrusts in a future follow-on Phase II effort. In addition, during the Phase II effort, we may further improve the basic contractile hydrogel dressing technology platform by including hydrogel phase transition triggered slow release of growth factors, antimicrobials and mmp inhibitors. The eventual commercial availability of such a novel wound dressing technology is likely to sustain high positive impact in the quality of life within the patient populace suffering from chronic wound types.
This proposed study will sustain high positive impact in the field of accelerated chronic and acute wound healing and is specifically devised to provide proof-of-concept for the feasibility of our contractile hydrogel dressing technology. The study if successful will also sustain high commercial impact in the medical wound dressing marketplace as it is expected to be a multifunctional wound healing product. The potential benefits to the approximately 27 million citizens suffering from DFU are numerous including lowered pain, faster wound healing times, better healing outcomes from both a physiological as well as a cosmetic standpoint and lowered cost of treatment.