Methods to Minimize Risks Clause Samples

Methods to Minimize Risks. ‌ Investigators will be licensed physicians in good standing. Trial centers and investigators will be selected on the basis of experience with DFU pathology, diagnosis and treatment. Investigators and study personnel will be trained on application of the product and the protocol. The inclusion/exclusion criteria are consistent with the labeled indications and contraindications of MIRODERM Biologic Wound Matrix and will assure that only subjects who are appropriate for treatment with this product are enrolled. Regular monitoring of the subjects’ condition and tracking of adverse events (AEs) related to the device and trial will allow for the quick identification of potential problems with an individual subject as well as the entire cohort. Again, MIRODERM Biologic Wound Matrix is a commercially available device being used as indicated. The risk to the patient participating in this study is not fundamentally different than that of a patient undergoing treatment for a DFU using a porcine derived biologic wound matrix and not participating in a study.