Evaluating the Efficacy of Perinatal Membrane Allografts in Addition to the Standard of Care for the Treatment of Non-healing Diabetic Foot Ulcers.

The dual-layer perinatal tissue allograft is an amnion - amnion allograft

The three-layer fenestrated perinatal tissue allograft is an amnion - chorion - amnion allograft

Standard of care (SOC) will include cleansing of the index wound with sterile normal saline solution, followed by sharp debridement to remove necrotic tissue, application of appropriate dressings and wound off-loading.