Pressure ulcers (PUs), commonly referred to as bed sores, affect 2.3 million individuals annually in the US. Treatment cost of PUs, exceeded $11 billion in 2006 or $43,180 per patient. To address rising expenditures associated with preventable conditions, Medicare ceased reimbursement for treatment of facility-acquired PUs in 2008. In response, current clinical PU management protocols focus on prevention and early detection (stage-I PU). However, the standard clinical PU diagnostic test, the manual Blanch Test (MBT) has significant limitations. The MBT requires a caregiver to visualize color changes to a specific area of skin when pressure is applied and feel changes in the properties of the skin. This widely used method presents significant limitations including subjectivity, low accuracy, especially on dark skin tones, and low of repeatability and reliability. These deficiencies result in a significant unmet public health need to accurately detect the precursors of early stage PUs. To address this problem, Rubitection Inc.'s long term goal is to commercialize the Rubitect Assessment System (RAS), a safe and low cost non-invasive bed-side system that includes a measurement probe and PU risk management software. The RAS will allow caregivers to perform a reliable blanch test that quantitatively detects the presence of a bedsore on all skin tones or estimate the risk of a PU. Preliminary bench top research has demonstrated that the RAS' probe can reliably detect the diagnostic cues of a stage 1 PU, independent of a patient's skin color. This Phase 1 SBIR proposes to achieve 2 aims that build upon these findings: 1.) complete an initial clinical validation study of the RAS' probe to characterize its diagnostic performance on patients, and 2.) investigate the feasibility of an earl risk-assessment software that predicts the progression of a PU. The probe's sensitivity will be quantified by testing prototypes of the device on 25 lightly and 25 darkly pigmented patients in long term care facilities. Results collected from the RAS will be compared with the standard of care (MBT) via patient records to calculate sensitivity using a 2x2 Contingency Table. Aim 2 will test the feasibility of a PU risk estimation software that can analyze changes in the skin's properties to estimate localized risk of an impending PU. The software will be bench top tested with pre-classified data using a 2x2 Contingency Table to determine its sensitivity/accuracy in correctly PU risk. The successful completion of the Phase I SBIR will provide the initial pilot dat to demonstrate the feasibility of the RAS as a diagnostic tool for early stage bedsores, and a proof of concept software platform for early PU risk assessment. The follow-on Phase II SBIR will refine the design of the RAS probe and software for optimized performance and clinical userability. Upon completion of R&D the RAS will be commercialized to provide healthcare facilities with a low cost solution to early PU management. The RAS will enable caregivers to reliably and safely detect PUs at their earliest stage and thus yield better patient outcomes, improved documentation, and lower associated costs.
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