The University of Arizona Wound Care Center Clinical Research Unit

PROJECT SUMMARY Approximately 25% of diabetic patients experience diabetic foot ulcers (DFUs). This is a significant clinical problem since there are no effective biomarkers for predicting outcomes, no drug candidates that have recently been FDA-approved and no therapies that are widely effective in treatment. Additionally, the prevalence of diabetes and non-healing DFUs are highest among minorities, such as in Native American and Hispanic populations, and associated with social deprivation and high mortality. The University of Arizona (UArizona) is the leading public research university in the American Southwest and an ideal transdisciplinary research community for studying DFU healing. The partnership between UArizona and Banner Health provided service to 5,680 patients with open wounds last year. Ranging from trauma to podiatry, Banner Health saw 3,770 individuals with diabetic foot ulcers (DFUs) in the past 3 years. Dr. Geoffrey Gurtner has an established history in studying both late-stage biomarker validation through clinical trials and also mechanistic and early-stage biomarkers identification through the collection of many high-quality biosamples and longitudinal data (Aim 1). This is supported by both the large patient population at UArizona as well as Dr. Gurtner’s history in identifying rate cell subpopulations in DFU samples collected from human patients. Next, we aim to create a unified Standard of Care through the execution of high-quality clinical trials for DFUs, which historically have been difficult to recruit, and also by collecting high-quality data to address the heterogeneity of DFUs with complex pathologies, co-morbidities, and social factors. At UArizona, Dr. Gurtner and Dr. Zhou conduct high-quality clinical trials and have access to a wide distribution of patients and a range of techniques to make sure that “No DFU Patient Goes Unstudied” (Aim 2). Next, our diverse patient pool will allow us to specifically understand how social and environmental contextual factors (“social determinants of health”; SDH) may affect diabetic healing and biomarkers, specifically be recruiting over a diverse and expansive patient pool (Aim 3). Finally, we have access to not just the entire Banner Health Network (BHN), but also to the Indian Health Network and outreach programs for Latino communities. Through this expansive network that incorporates people of all demographics and socio-economic statuses, we will establish effective collaborations between the CRU and new clinical sites to generate cooperative problem-solving and high-level training, with shared resources and values (Aim 4).