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Member Profile

Klearchos Papas

Personal Information
Title Professor
Expertise None Selected
Institution University of Arizona
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Grants/SubContracts 1
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Publications 0
Protocols 0
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Experiments 0
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Clinical biomarker development for diabetic foot ulcers
Foot ulcers and diabetic wounds occur in at least a quarter of people with diabetes. These wounds severely reduce mobility and are a major cause of morbidity for diabetic patients. Almost half of diabetic foot ulcers (DFU) are complicated by concomitant ischemia, and associated infection and elevated inflammatory response, which appears to interfere with healing ability. DFU, which affect approximately 3-4 million people in the US each year, are the most common cause of lower leg amputations. Despite significant efforts to prevent chronic diabetic non-healing wounds and amputations, half of the DFU patients develop infection, which in 20-30% of cases, still leads to some level of amputation, yielding one amputation every 20 seconds, worldwide. There is a clear and unmet need for reliable, cost-effective validated non-invasive biomarkers and diagnostics that assess and predict healing capacity and help further develop and guide effective interventions that ultimately result in healing and prevent amputations. Emerging literature suggests that oxygenation levels near the wound (especially following an oxygen challenge) can predict wound healing ability with good specificity and sensitivity. Furthermore, molecular biomarkers from fluid removed from the wound may also be indicative of healing potential and point to the importance of oxygenation status. However, currently available in vivo methods for oxygen measurements are costly, require complex instrumentation, and a visit to a physician’s office and recent evidence indicates that many DFU have an active infection or elevated immune response that if undetected and if untreated leads to worse outcomes. The purpose of this proposal is to bring together a multidisciplinary team (Dr. Papas and Dr. Armstrong, at the University of Arizona, Dr. Natalie Wisniewski, Profusa and Dr. Richard Collette, WOUNDCHEK LABORATORIES) with expertise in the development, standardization and validation of clinical bioassays, in oxygen measurements in cells and tissues, as well as, the clinical management and treatment of DFU, for the ultimate development of a multi-center properly powered study to investigate cost-effective, noninvasive real-time oxygen measurements near DFU (and key related molecular biomarkers) for their ability to predict healing of DFU. Specifically, with this partnership in the current planning proposal we aim: 1) To perform a pilot clinical study (in two groups of five diabetic patients with “healing” and “non-healing” wounds) using novel, miniaturized fully-implanted wireless oxygen sensors developed by Profusa to monitor oxygen concentrations near DFU, while simultaneously measuring novel clinical molecular biomarkers that appear to be associated with oxygenation status and correlate with wound healing ability (developed and being investigated by WOUNDCHEK LABORATORIES); 2) utilize the pilot data from 1 and work with the DiaComp Consortium and NIDDK to design and submit a properly powered multi-center clinical trial to validate and assess the utility of these biomarkers, including tissue-level oxygen around the wound, in predicting wound healing outcomes, which then in turn may be used to re-direct therapeutic options for DFU.

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