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NCT04647240 · ClinicalTrials.gov registry record · Phase 2
Dermacyte® Amniotic Wound Care Liquid for the Treatment of Non-Healing Venous Stasis Ulcers
A Phase 2 study of Venous Leg Ulcer and Venous Stasis Ulcer, sponsored by Merakris Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 9
- Study locations
NCT04647240 is a Phase 2 study of Venous Leg Ulcer and Venous Stasis Ulcer that is actively recruiting participants, run by Merakris Therapeutics. The registered enrollment target is 50 participants, below the 244-participant average among 35 other Venous Leg Ulcer trials with a reported enrollment target (80% lower). The trial reports 9 study locations across 6 states.
The verdict
NCT04647240, a Phase 2 study of Venous Leg Ulcer and Venous Stasis Ulcer, is actively recruiting participants, sponsored by Merakris Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 9
- Study locations
Study 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 Dermacyte® Liquid (MTX-001).
Conditions Studied
Interventions
- BIOLOGICAL Dermacyte® Liquid (human amniotic fluid)
Study Locations (9)
California
- Center for Clinical Research, Inc. - Castro Valley
- Limb Preservation Platform, Inc. - Fresno
- Center for Clinical Research Inc. - San Francisco
- Center for Clinical Research, Inc. - San Francisco
Arizona
- Compass Medical Research Center - Tucson
Massachusetts
- Massachusetts General Hospital - Boston
New York
- Northwell Health, Inc. - New Hyde Park
Ohio
- Brock Liden DPM - Circleville
Virginia
- Salem Vamc - Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2022-02-26 |
| Est. Completion | 2025-10-15 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04647240
The ClinicalTrials.gov registry entry for NCT04647240 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 244-participant average among 35 other Venous Leg Ulcer trials with a reported enrollment target (80% lower). The listed sponsor is Merakris Therapeutics, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Venous Leg Ulcer appearing as the primary indexed condition, and to 1 intervention - of which Dermacyte® Liquid (human amniotic fluid) is the first listed.
NCT04647240 reports 9 study locations spanning 6 distinct geographic areas - top geographies include California, Arizona, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04647240 about?
NCT04647240 is a clinical study titled "Dermacyte® Amniotic Wound Care Liquid for the Treatment of Non-Healing Venous Stasis Ulcers". 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 (M...
What is the current status of trial NCT04647240?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2022-02-26. Estimated completion is 2025-10-15.
What conditions does trial NCT04647240 study?
This clinical trial studies the following conditions: Venous Leg Ulcer, Venous Stasis Ulcer.
What interventions are being tested in trial NCT04647240?
The interventions under investigation include: Dermacyte® Liquid (human amniotic fluid) (BIOLOGICAL).
Who is sponsoring clinical trial NCT04647240?
This trial is sponsored by Merakris Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04647240 being conducted?
This trial has 9 study locations across Arizona, California, Massachusetts, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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