Approximately 25% of diabetic patients experience diabetic foot ulcers (DFUs). This is a significant clinical problemsincetherearenoeffectivebiomarkersforpredictingoutcomes,nodrugcandidatesthathaverecently been FDA-approved and no therapies that are widely effective in treatment. The Stanford Advanced Wound Care Center (AWCC) was opened in 2014 with the sole purpose of facilitating clinical trials, conducting translational research and providing care for patients with chronic wounds. Stanford AWCC receives patients fromtheUniversityHealthcareAlliance,whichspans60clinicsand2.5millionpeopleintheSanFranciscoBay Area. Despite being in a relatively prosperous area, Stanford AWCC treats patients from diverse socio- demographics.Inthepasttwoyears,Stanfordhastreated6000patientswithwounds,ofwhom705hadDFUs. 50% of the patients enroll in clinical trials and there is a very low dropout rate (less than 5%). Under Dr. Geoffrey Gurtner?s leadership, the Stanford AWCC has conducted over 25 clinical trials, where we have measuredbiomarkersandtestednoveltherapeuticinterventions(Aim1). ItisknownthatwoundhealingtrialsexperienceasignificantlyhigherfailurerateinPhaseIIIstudiescompared to any other drug trial. This is primarily due to the poorly controlled procedural component of wound care. At Stanford, we address these issues by (i) practicing a multi-disciplinary approach overseen by physicians, (ii) standardizing the measuring and reporting of healing outcomes, (iii) emphasizing rigorous and efficient operational processes during clinical trial conduct and (iv) collaborating with other major academic centers (Aim 2). Looking forward, it is critical to optimize patient engagement during their treatment regimens and inculcate a shared decision-making process. Clinical studies in medical fields such as cancer have indicated that such patient-centered approaches lead to the adherence of treatment regimens and clinical trials. This is currently lacking in with patients with DFUs. With Dr. Arden Morris?s expertise, the Stanford AWCC practices newapproachesthatcentersaroundthepatient,withafocusonimprovementintheirqualityoflife(Aim3). Dr. Nigam Shah, the Director of Bioinformatics at Spectrum, Stanford?s Clinical and Translational Sciences Award has worked with the Stanford AWCC and developed computational tools that predict wound healing outcomes.ThesemodelshavebeendevelopedusingdatafromtheHealogicsdatabase,thecountry?slargest network of wound care clinics and a Stanford AWCC operational partner. Dr. Shah also has expertise in analyzingelectronichealthrecordsofpatientsfromlargedatabasessuchasTRUVENandOPTUM,whichwill allow for the determination of unique biomarkers for wound healing through computational modeling. These modelscanbeexecutedacrosstheentireDiabeticFootConsortium(Aim4).

Public Health Relevance

The Stanford Advanced Wound Care Center (AWCC) was opened in October 2014 to fill both a clinical and academic need by integrating clinical trials and research in wound care. Since its launch, the number of patients with DFUs at Stanford AWCC has doubled in each of the past two years and the unit has been financially successful, ensuring its long-term viability. Here, we demonstrate the ability of Stanford AWCC to serve as a Clinical Research Unit (CRU) by displaying access to patients with DFUs from a wide sociodemographic,emphasizingqualityofclinicalresearchconducted,demonstratingwaysofpatient-centered collaborativedecisionmakingandusingbigdatatoaccuratelypredictandquantifywoundhealingoutcomes.

National Institute of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Research Project--Cooperative Agreements (U01)
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Special Emphasis Panel (ZDK1)
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Burch, Henry B
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Stanford University
Schools of Medicine
United States
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