NCT04647240 · Merakris Therapeutics
Dermacyte® Amniotic Wound Care Liquid for the Treatment of Non-Healing Venous Stasis Ulcers
What this study is about
DL-VSU-201 is a randomly assigned, where neither patients nor doctors know which treatment is given, 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 effectiveness and safety of Dermacyte® Liquid (MTX-001).
View original scientific description
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 Dermacyte® Liquid (MTX-001).
Interventions
BIOLOGICAL
MTX-001 (human amniotic fluid)
Subcutaneous injection into and/or around wound bed weekly
Primary outcome measures
Safety and tolerability
Time frame: Baseline to Week 12
Evaluated via patient and/or Investigator reported adverse events that occur during the study
Preliminary efficacy
Time frame: Baseline to Week 4
Assessed by percentage area reduction of the ulcer surface area from Baseline to Week 4.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Subjects who voluntary give written informed consent to participate in study
- Males and female subjects aged 18 to 75 years inclusive at Screening (date the subject provides written informed consent to participate in study) for Part 1 only
- Males and female subjects aged 18 to 80 years inclusive at Screening (date the subject provides written informed consent to participate in study) for Part 2 only
- Subjects must have a full thickness ulcer that meets the following criteria:
- Ulcer surface area \> 1 cm2 and \< 25 cm2
- Ulcer surface area hasn't increased or decreased by 25% or more, as assessed within 14 days or more prior to Baseline
- Ulcer depth \> 0.2 cm at the deepest point of the wound, as measured by gently inserting a pre-moistened cotton tipped applicator into the deepest part of the wound.
- Ulcer age \< 12 months (365 days) prior to Baseline (for Part 2 only)
- Received \> 28 days of standard, conventional wound therapy with a high-compre
Where
- Tucson, Arizona
- Castro Valley, California
- Fresno, California
- San Francisco, California
- Vista, California
- Tampa, Florida
- Opelousas, Louisiana
- New Hyde Park, New York
- Circleville, Ohio
- Salem, Virginia
Collaborators
US Department of Veterans Affairs
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 22, 2026 · Source of record for eligibility and locations