CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 80 target
Drug / intervention
MTX-001 (human amniotic fluid)biological
Likely dose
0.2 mLfrom record
Key inclusion· 16
  • ✓Written informed consent
  • ✓Age 18-75 years (Part 1)
  • ✓Age 18-90 years (Part 2)
  • ✓Full-thickness ulcer 4-25 cm² surface area
Key exclusion· 18
  • ✕Currently receiving topical antimicrobials or ulcer infected per IWII criteria
  • ✕Exposed bone, tendon, or ligament
  • ✕Another ulcer within 2 cm of treatment ulcer
  • ✕Pregnancy, lactation, or planning pregnancy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04647240
NCT04647240Phase 2RecruitingOn Track
Long Recruiting
CompareCT.gov

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

Merakris Therapeutics·interventional·Posted Nov 30, 2020·Updated Jun 22, 2026

In Brief

A Phase 2 clinical trial evaluating MTX-001 (human amniotic fluid) for Venous Stasis Ulcer and Venous Leg Ulcer. Currently recruiting, targeting 80 participants across 11 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVenous Stasis Ulcer, Venous Leg Ulcer
CountriesUnited States
CollaboratorsUS Department of Veterans Affairs

Timeline

Phase 2Recruiting
2021202220232024202520262027
First PostedNov 30, 2020
Enrollment StartFeb 26, 2022
Primary CompletionMar 31, 2027
Study CompletionMay 31, 2027
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 5.6 years agoPrimary completion in 9 months

Arms & Interventions

MTX-001active_comparator

MTX-001 (human amniotic fluid) solution 0.2 mL/sqcm weekly

Biological: MTX-001 (human amniotic fluid)
Placebo (0.9% saline)placebo_comparator

Matching placebo solution 0.2mL/sqcm weekly

Biological: MTX-001 (human amniotic fluid)

Interventions

MTX-001 (human amniotic fluid)biological

Subcutaneous injection into and/or around wound bed weekly