NCT04647240

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

A Two Part, Randomized Study of MTX-001 for the Treatment of Non-Healing Venous Stasis Ulcers

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Merakris Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 will receive localized subcutaneous injection of MTX-001 or placebo into and/or around the wound bed during weekly clinic visits over a 12-week period and assessed for safety and efficacy measures at Screening, Baseline, and Weeks 4, 8, and 12. Percent reduction of the wound surface area will be formally collected at Baseline, Weeks 4, 8, and 12. To assess healing, the ulcer will be evaluated by assessing the change in the surface area from Baseline. Overall change in VAS from Baseline to Week 12 will be evaluated and total wound closure will be evaluated at Week 12.

Conditions

• Venous Stasis Ulcer
• Venous Leg Ulcer

Interventions

Type	Name	Description
BIOLOGICAL	MTX-001 (human amniotic fluid)	Subcutaneous injection into and/or around wound bed weekly

Timeline

• Start date: 2022-02-26
• Primary completion: 2027-03-31
• Completion: 2027-05-31
• First posted: 2020-11-30
• Last updated: 2026-04-17

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study