This study will evaluate two human amnion/chorion membrane (ppLHACM) products and Standard of Care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs).
At least 18 years of age or older.
Diagnosis of type 1 or 2 Diabetes mellitus.
At randomization subjects must have a target ulcer with a minimum surface area of 0.7 cm² and a maximum surface area of 5.0 cm² measured post debridement.
The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care, prior to the initial screening visit.
Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to enrollment.
The potential subject must consent to using the prescribed offloading method for the duration of the study.
The potential subject must agree to attend the weekly study visits required by the protocol.
The potential subject must be willing and able to participate in the informed consent process.
MiMedx Group, Inc.
Lead sponsor
SerenaGroup, Inc.
Collaborator