MTX-001 for the Treatment of Non-Healing Venous Stasis Ulcers

Inclusion Criteria: * Patients who voluntarily give written informed consent to participate in study * Males and female patients aged 18 to 75 years inclusive at Screening (date the patient provides written informed consent to participate in study) for Part 1 only * Males and female patients aged 18 to 90 years inclusive at Screening (date the patient provides written informed consent to participate in study) for Part 2 only * Patients having a full thickness ulcer that meets the following criteria: * Ulcer surface area ≥ 4 cm2 and \< 25 cm2 * Ulcer surface area hasn't increased or decreased by 40% or more, as assessed within 28 days prior to Baseline * Ulcer depth ≥ 0.2 cm at the deepest point of the wound, as measured by gently inserting a pre-moistened cotton tipped applicator into the deepest part of the wound. * Ulcer age \< 36 months (1095 days) prior to Baseline (for Part 2 only) * Received ≥ 28 days of standard, conventional wound therapy with a therapeutic high-compression (≥40 mmHg), multilayer bandaging (e.g. compression hose, custom garments, commercial kits, etc.) prior to the Baseline visit. If clinically necessary, patients may have received other wound treatments as needed (e.g., surgical debridement, pressure offloading, negative pressure and/or hyperbaric oxygen therapy). * Patient must have previously undergone venous hemodynamic correction via therapeutic compression (≥40 mmHg), surgical venous stripping, sclerotherapy, endovenous laser ablation,…