Randomized Phase 2 Study of MTX-001 Injection for Treating Non-Healing Venous Stasis Ulcers

What this Trial Is About

Researchers are evaluating the safety and effectiveness of MTX-001, a treatment for non-infected venous stasis ulcers VSUs that have not improved after at least four weeks of standard wound care. This randomized, double-blind, placebo-controlled Phase 2 study involves patients who have chronic wounds and aims to compare MTX-001 to a placebo when given alongside usual wound therapy. The study is conducted at multiple centers and includes a lead-in phase to determine dosing frequency, followed by a randomized treatment phase. Participants receive subcutaneous injections of either MTX-001, which is human amniotic fluid, or a placebo solution injected into and around the wound once weekly during clinic visits for 12 weeks. The trial includes a lead-in phase where dosing frequency was assessed and a main phase where approximately 70 patients are randomized 11 to receive either MTX-001 or placebo along with standard care. Treatment is given weekly as needed over the 12-week period. Throughout the study, participants are assessed at screening, baseline, and weeks 4, 8, and 12 for safety and wound healing progress. Measurements include wound surface area reduction, total wound closure, pain changes, quality of life, and global impression of change. Researchers track healing by comparing wound size from baseline to follow-up visits. The study monitors safety and tolerability from baseline to week 12. Participation covers the entire 12-week treatment and observation period.

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