• Subjects must be at least 18 years of age or older.

• Subjects must have a diagnosis of a venous leg ulcer (confirmed by clinical and duplex ultrasound evaluation).

• At enrolment subjects must have a target VLU with a minimum surface area of 2.0 cm2 and a maximum surface area of 25.0 cm2 measured post debridement using a ruler to measure wound area.

• 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.

• The target ulcer must be located on the foot, ankle and lower leg region.

• The target ulcer must be full thickness on the foot or ankle that does not probe to bone.

• Adequate circulation to the affected foot as documented by any of the following methods performed within 3 months of the first screening visit:

⁃ i. TCOM ≥30 mmHg ii. ABI between 0.7 and 1.3 iii. PVR: Biphasic iv. TBI ˃0.6 v. As an alternative arterial, Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle of the target extremity.

⁃ h. If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.

⁃ i. The subject must consent to using the prescribed off-loading method for the duration of the study.

⁃ j. The subject must agree to attend the twice-weekly/weekly study visits required by the protocol.

⁃ k. The subject must be willing and able to participate in the informed consent process.

⁃ l. Patients must have read and signed the IRB approved ICF before screening procedures are undertaken.