A Two Part, Randomized Study of MTX-001 for the Treatment of Non-Healing Venous Stasis Ulcers
Merakris Therapeutics
Summary
DL-VSU-201 is a randomized, double-blind, placebo-controlled study in subjects with a non-infected venous stasis ulcer (VSU) that has failed to demonstrate improvement after receiving at least 4 weeks of standard, conventional wound therapy to evaluate the efficacy and safety of MTX-001.
Description
DL-VSU-201 is a multi-center, two-part study in patients with VSU (n=80). The lead-in phase of the study (Part 1) enrolled 11 eligible patients. In Part 1, patients were allocated to receive active MTX-001 once weekly or once every two weeks with standard of care. After completion of Part 1, the data was reviewed to determine the administration frequency of Study Product in Part 2 of the Study. In Part 2, approximately 70 patients will be randomized 1:1 to receive MTX-001 or placebo (0.9% NaCl) with standard of care. Patients will be administered study treatment weekly, as needed. Patients w…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 decre…
Interventions
- BiologicalMTX-001 (human amniotic fluid)
Subcutaneous injection into and/or around wound bed weekly
Locations (10)
- Compass Medical Research CenterTucson, Arizona
- Center for Clinical Research, Inc.Castro Valley, California
- Limb Preservation Platform, Inc.Fresno, California
- Center for Clinical Research Inc.San Francisco, California
- Center for Clinical Research, Inc.San Francisco, California
- ILD ResearchVista, California