Nonhealing Diabetic Foot Ulcers Treated With Standard of Care (SOC) Alone or Standard of Care and Amnion-Intermediate-Chorion (AIC)

The purpose of this study is to determine how well our dHPT (Dehydrated Human Placental Tissue) Product and Standard of Care work when compared to Standard of Care alone in achieving complete closure of diabetic foot.

Chronic wounds affect a significant percentage of patients over their lifetime. For example, diabetic foot ulcers (DFU) are a major health complication that affect up to 15% of individuals with diabetes mellitus over their lifetime. The treatment of chronic wounds is extremely challenging as ulcers such as DFUs may not respond to standard of care (SOC) treatment and frequently become infected. Advanced wound products like Dehydrated Human Placental Tissue (dHPTs) have become an important strategy in the treatment of these chronic wounds by trapping and binding the patients' own cells to rebuild the dermis layer of the skin to aid in healing. This study will evaluate the clinical utility of Amnion-Intermediate-Chorion (AIC) in the closure of diabetic foot ulcers in subjects in comparison to Standard of Care treatment.