New gel aims to heal stubborn leg ulcers

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria 1. Subjects with venous leg ulcers (VLU), defined by open skin lesion of the leg as a result of venous hypertension. 2. Subject must be ≥ 18 years of age. 3. Active lower extremity ulceration (CEAP classification of C6). 4. Non-healing VLU ≥ 4 weeks but not greater than 24 months. 5. Ulcer size ≥ 2cm2 ≤ 20cm2. a. Target ulcer will be defined as the largest ulcer on the affected limb. Only one wound per subject will be designated as the study wound and treated with the investigational gel. If a subject has two wounds separated by less than 1 cm of intact skin, these wounds will be considered a single study wound, and the surface areas of both wounds will be added together for eligibility purposes; if the combined area exceeds 20 cm², the subject will be excluded from the study. Although only one wound will be directly treated, local activation of the MAPK pathway may result in biological stimulation of the adjacent untreated wound when wounds are separated by less than 1 cm. 6. Chronic venous insufficiency confirmed by ultrasound within previous 12 months. 7. Adequate perfusion confirmed within the past 12 months.: 1. Dorsalis Pedis (DP) or Posterior Tibial (PT) systolic pressure ≥ 60mmHg on the study limb. 2. Transcutaneous partial pressure oxygen (TcP02) \> 30mmHg. 3. Great toe systolic pressure \> 40mmHg. 8. Must be able and willing to provide informed consent prior to study participation. 9. Female subjects of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at baseline (Day 0). They should agree to use highly effective methods of birth control, defined as those with failure less than 1%, such as implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices (IUD's), sexual abstinence, or a vasectomized partner. Such subjects should agree to have monthly pregnancy test documented. Exclusion Criteria 1. Target ulcer has exposed of tendon, muscle, or bone. 2. Target ulcer is of non-venous etiology. 3. Target ulcer has been treated with living cellular therapy within 4 weeks of the randomization. 4. Target ulcer shows any signs of infection (only non-infected ulcers are eligible). 5. Patient has undergone endovenous ablation or other venous surgery within 4 weeks of enrollment. 6. Unable to tolerate multi-layer bandages or compression garments. 7. Decompensated congestive heart failure within 4 weeks of screening. 8. Active soft tissue or bone infection requiring antibiotics. 9. Skin cancer on the target limb within the last 24 months. 10. Actively receiving chemotherapy and/or radiation therapy for cancer. 11. Treatment with a serine/threonine-protein kinase BRAF inhibitor, including but not limited to Zelboraf® (vemurafenib), Tafinlar® (dabrafenib), BraftoviTM (encorafenib) or Nexavar® (sorafenib), within 30 days or 5 half-lives of the drug prior to Screening, whichever is longer. 12. Blood chemistry or counts values as follows: 1. White Blood Cells (WBC)\< 1.5 x 109/L. 2. Absolute \< 0.9 x 109/L. 3. Platelet count \< 50 x 109/L. 4. Alanine aminotransferase \> 3 x upper limit of normal. 5. Aspartate aminotransferase \> 3 x upper limit of normal. 6. Serum albumin \<2.0 g/dL. 7. HbA1c value of \> 12% within the past three (3) months. 13. Current use of systemic corticosteroids \> 5 mg daily or equivalent within 4 weeks. 14. Currently pregnant or trying to become pregnant. 15. Inability or unwillingness to participate in all aspects of study protocol or as determined by the Investigator. 16. Known hypersensitivity to the ingredients of the study drug.