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DiaComp Funded Abstracts Collaborative Funding Program Funding Programs

Collaborative Funding Program Application Abstract
Cortisol synthesis enzyme, CYP11B1, as tissue biomarker for diabetic foot ulcers
Marjana Tomic-Canic   (Miami, FL)
We plan to develop a robust clinical trial aimed at extending our preliminary observations and further validating CYP11B1 as a biomarker associated with progression and healing of diabetic foot ulcers (DFUs). Based on strong scientific data and extensive preliminary evidence from previous clinical trials, we have selected the cortisol pathway as significantly associated with healing outcomes. Specifically, we propose the cortisol synthesis enzyme CYP11B1 as a tissue biomarker of interest. Our data show that the levels of CYP11B1 correlate with DFU healing outcome. We hypothesize that cortisol in the tissue of neuropathic and neuroischemic DFUs can serve as a predictive biomarker of healing outcomes in patients receiving standard of care treatment for their DFUs, and may serve as a therapeutic target for intervention or to inform treatment decisions. Our collaborative international team of experienced and renowned physicians and scientists has generated one of the largest DFU tissue biomarker data sets and tissue banks that will be utilized in this planning proposal. In order to prepare for this significant undertaking we will plan for the larger biomarker grant by outlining two specific aims: Aim 1 will create an administrative core which will develop the future clinical trial including investigator and site selection, clinical and laboratory methodologies, data collection and storage, investigative approach and logistics in preparation for a large clinical multi-center study of biomarkers for prediction of responsiveness to treatment of neuropathic and neuroishemic DFUs. In the Aim 2 we will optimize methodology and confirm reproducibility of CYP11B1 measurement, established from previous collaborative work in patients receiving standard care. This planning grant will allow our team to conduct a well designed multicenter trial to show the utility of tissue derived cortiosol marker CYP11B1 to predict the healing of DFUs encountered in clinical practice and therefore determine if changes in tissue cortisol status can be used as a targeted therapeutic intervention.
Data for this report has not yet been released.