Standard of Care in Diabetic Foot Ulcers (DFUs)
This prospective, multi-center, randomized, controlled clinical study compares NuShield® plus SOC to SOC alone in subjects with chronic DFUs. NuShield® will be used along with standard of care on diabetic foot ulcers of greater than 6 weeks which have not adequately responded to conventional ulcer therapy … One hundred and twenty five (125) subjects with a chronic DFU ranging in size from 0.5cm2 and 25 cm2 will be randomized 1:1 to either NuShield® and SOC or SOC alone following the 14 day screening period. Following screening and randomization, subjects shall be seen weekly for up to 24 weeks. For subjects that heal prior to week 24, a healing confirmation visit shall occur two weeks later to confirm maintenance of complete wound closure … read more