Modulated Imaging Inc. — Department of Health and Human Services SBIR Phase II: 200

Description

ABSTRACT Diabetes mellitus affected million adults worldwide in and is expected to increase in prevalence to million people by the year Foot ulceration continues to be a major comorbidity of diabetes and afflicts as many as of subjects with type and diabetes during their lifetime Lower limb amputations due to poor DFU management are a global burden that is associated with a year mortality rate and cumulatively costs the system approximately $ per patient Effective prevention and treatment of foot ulcers can be hindered due to a lack of objective standards to quantitatively track foot health and assess treatment outcomes The broad goal of this research is to develop Modulated Imaging a new clinically viable tool which provides quantitative insight into disease stage progression and therapeutic response into a clinically viable tool for screening and managing diabetic foot ulcers MI is a non contact imaging technology that determines the in vivo concentrations of subsurface chromophores relevant to tissue health i e hemoglobin oxygenation edema and scattering The goal of this proposal is to develop a user friendly dedicated MI platform system for studying the value of MI derived biometrics like hemoglobin oxygenation and scattering in the diabetic foot In this Phase II program we will build a DFU MI device and perform three pilot studies to assess the capability of our technology to impact diabetic foot care First we will characterize vascular reactivity in control and feet considered at risk for ulcer to determine normative MI biometrics Second we will study our ability to predict new wound formation in feet that are considered in remission but with a andgt chance of re ulceration Finally we will study lower limb perfusion changes after vascular intervention for and existing wound to assess efficacy prior to wound closure Our Phase II research will determine the insertion point of MI technology into DFU clinical care and provide insight to future Phase III clinical study hypotheses and designs in order to build a medical imaging device with indications specific to wound prediction and healing NARRATIVE Effective prevention and treatment of foot ulcers can be hindered due to a lack of objective standards to monitor progression The goal of this research is to develop Modulated Imaging a new optical technology which provides quantitative insight into disease status and therapeutic response into a clinically viable tool for screening and managing diabetic foot ulcers