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

Start date
Feb 26, 2022
Status verified
Apr 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 (10)

FacilityCityStateZIPSite coordinators
Compass Medical Research CenterTucsonArizona85715-
Center for Clinical Research, Inc.Castro ValleyCalifornia94546-
Limb Preservation Platform, Inc.FresnoCalifornia93710-
Center for Clinical Research Inc.San FranciscoCalifornia94115-
Center for Clinical Research, Inc.San FranciscoCalifornia94117-
ILD ResearchVistaCalifornia92081
Dean Vayser, DPM
(760) 350-5080
Massachusetts General HospitalBostonMassachusetts02114-
Northwell Health, Inc.New Hyde ParkNew York11042-
Brock Liden DPMCirclevilleOhio43113-
Salem VamcSalemVirginia24153
YVETTE SPANGLER

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By research site
Compass Medical Research Center· Tucson, AZCenter for Clinical Research, Inc.· Castro Valley, CALimb Preservation Platform, Inc.· Fresno, CACenter for Clinical Research Inc.· San Francisco, CACenter for Clinical Research, Inc.· San Francisco, CAILD Research· Vista, CA

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