PROGENITEC INC — Department of Health and Human Services SBIR Phase II: NIAMS

Description

Chronic non healingcharacterized by minimal or no scarringand infected wounds continue to pose great challenges by burdening patientswound care specialistsand the health care systemIt is estimated that there aremillion new chronic wound patients each year and approximatelymillion Americans suffer from chronic woundsTo make the situation worsechronic wounds often predispose patients to infectionIt is also not uncommon to have necrotic tissue on one side and epithelializing tissue on the other sideWhile wound treatmentssuch as debridementcan remove dead tissue and restart the healing processsuch procedures can also damage healing tissue and delay healingThereforea targeted and localized wound treatment is believed to substantially improve wound healing outcomeUnfortunatelysuch strategies are difficult to implement due to lack of effective methods to diagnose and monitor the wound healing status of different wound areasThere is an urgent and unmet need for the development of a new wound monitoring and diagnosis technique which is the focus of this investigationMany biomolecules have been found to play an important role in wound healing responsesHoweverthese biomolecules cannot be used as universal indicators of wound healing due to their large variation and instability among patients in different disease conditionsMany recent studies have shown that wound pH is a good indicator of wound conditionsSpecificallyacidic environment provides fertile condition for cell proliferationand angiogenesis while impeding bacterial growthOn the other handalkaline wounds impair cell growth while favoring bacterial colonizationWe thus assume that a technology developed to detect wound pH and bacterial presence can be used as a means for quick wound diagnosis and monitoring healingTaking advantage of the recent developments in optical imaging technology and our Phase I workthe overall goal of this Phase II project is to fabricate and then validate two new productspHbacteria detecting diagnosis probe kit and pH sensing wound dressingfor non healing infected wound diagnosis and monitoring in humanFor the development of such productswe will first optimize the condition for the fabrication of both productsThis will maximize the ability of diagnosis kit to detect pH changes and bacteria presence and enable the wound dressing to map pH distribution in vitroAimThe in vivo efficacy of both diagnosis kits and wound dressing to detect chronic and infected wounds will be evaluated using porcine skin wound infection modelsAimThe products will then be evaluated in a pre clinical study using discarded wound gauzes from patients with different wound condition and treatmentsAimThe work will allow us to develop new products for wound monitoring while gathering critical data to seek FDA approval towards commencement of human studies in the near future