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A Novel Diagnostic Assay to Predict Healing and Non-healing of Diabetic Ulcers

(K. Spiller, M. Weingarten)

Abstract: The selection of an appropriate treatment strategy that is individually tailored to each patient from the dozens of choices available on the market is critical to success. This team has previously shown that discontinuing treatments that are ultimately ineffective may not only prevent deteriorating wounds from developing into further complications that can lead to limb amputation, but also would save approximately $10,000 to $60,000 per patient. Therefore, there is a need for a method to reliably and precisely indicate if a wound is healing or not. This team has developed a predictive assay that 1) measures direct indicators of healing, and 2) can be easily incorporated into the normal wound treatment regimen. Debrided wound tissue is analyzed by real time polymerase chain reaction (RTPCR), and a proprietary algorithm converts gene expression data using a panel of biomarkers to a single score that identifies the inflammatory state of the wound. By tracking the changes in the inflammatory state over time, the team has been able to accurately predict healing or non-healing of diabetic ulcers.