The purpose of this study is to evaluate the efficacy of two dehydrated human umbilical cord-based medical devices, also defined as Cellular, Acellular, Matrix-like Products/skin substitutes, plus SOC versus SOC alone in achieving complete closure of hard-to-heal venous leg ulcers over 12 weeks using a modified platform trial design.
At least 18 years of age or older.
Has a medical diagnosis of venous insufficiency with an open wound to the lower extremity.
At enrollment, target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 15.0 cm2 measured post debridement with the MolecuLight® Imaging Device.
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 must be treated with compression therapy for at least 14 days prior to enrollment.
The potential subject must consent to using the prescribed compression therapy 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.