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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Merakris Therapeutics
Study ID
NCT04647240
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MTX-001 (human amniotic fluid) — BIOLOGICAL
    Subcutaneous injection into and/or around wound bed weekly

Study Details

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.

Key Dates

First listed
Nov 30, 2020
Start date
Feb 26, 2022
Status verified
Aug 2026
Primary completion
Mar 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: MTX-001
    MTX-001 (human amniotic fluid) solution 0.2 mL/sqcm weekly
  • Placebo Comparator: Placebo (0.9% saline)
    Matching placebo solution 0.2mL/sqcm weekly

Primary Outcome Measure

Safety and tolerability [ Time Frame: Baseline to Week 12 ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
Site 02TucsonArizona85715-
Site 9CCastro ValleyCalifornia94546-
Site 16ALos AngelesCalifornia90033-
Site 9ASan FranciscoCalifornia94115-
Site 9BSan FranciscoCalifornia94117-
Site 16BSanta AnaCalifornia92704-
Site 13TampaFlorida33647-
Site 14OpelousasLouisiana70570-
Site 04New Hyde ParkNew York11042-
Site 08CirclevilleOhio43113-
Site 15HumbleTexas77338-
Site 01SalemVirginia24153-

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