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Biologic

Amniotic Fluid Therapy for Leg Ulcers

Phase 2
Recruiting
Research Sponsored by Merakris Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
VSU caused by underlying venous reflux disease with physiological reflux lasting greater than 500 milliseconds for superficial veins and 1.0 seconds for deep veins, as confirmed by most recent Doppler ultrasound venous mapping from Baseline; historical results within the last three years allowed
Must have previously undergone venous hemodynamic correction via compression, surgical venous stripping, sclerotherapy, endovenous laser ablation and/or endovenous radiofrequency ablation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to weeks 4, 8 and 12
Awards & highlights

Study Summary

This trial is testing a new wound care liquid on people with stubborn venous stasis ulcers that haven't healed with other treatments. The study is double-blind, meaning neither the patients nor the researchers will know who's receiving the real treatment or the placebo.

Who is the study for?
This trial is for adults aged 18-75 with non-healing venous stasis ulcers who've tried standard treatments without improvement. Participants must have had prior vein treatment, stable ulcer size, good blood flow in the affected leg, and an ulcer between 1 cm2 and 25 cm2. Exclusions include active skin grafts or regenerative therapies within the last month, infected ulcers, nearby additional ulcers, exposed bone at the ulcer site, limited mobility due to chronic conditions, or use of systemic corticosteroids.Check my eligibility
What is being tested?
The study tests Dermacyte® Liquid (human amniotic fluid) on leg ulcers that haven't healed with usual care. It's a randomized trial where patients are blindly assigned to receive either Dermacyte® Liquid or a placebo to assess effectiveness and safety.See study design
What are the potential side effects?
While specific side effects aren't listed here for Dermacyte® Liquid as it's under investigation, potential risks may include local reactions like redness or irritation at the application site. Since it's a blinded study involving human amniotic fluid-derived product versus placebo control group comparison will reveal side effect profile.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My leg ulcer is due to poor vein function confirmed by a recent ultrasound.
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I have had treatment to correct vein problems.
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My blood flow in the affected leg is within a healthy range.
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My ulcer is larger than 1 cm2 but smaller than 25 cm2.
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I have a deep, full-thickness wound.
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I am between 18 and 75 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to weeks 4, 8 and 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to weeks 4, 8 and 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and tolerability
Secondary outcome measures
Change in health-related quality of life
Change in pain
Total wound closure
+1 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Dermacyte® Liquid (human amniotic fluid)Active Control1 Intervention
Dermacyte® Liquid (human amniotic fluid) solution 1.0mL to 2.0mL weekly
Group II: Placebo (0.9% saline)Placebo Group1 Intervention
Matching placebo solution 1.0mL to 2.0mL weekly

Find a Location

Who is running the clinical trial?

Merakris TherapeuticsLead Sponsor
US Department of Veterans AffairsFED
868 Previous Clinical Trials
487,850 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Dermacyte® Amniotic Wound Care Liquid for the Treatment of Non-Healing Venous Stasis Ulcers
2022. "Dermacyte® Amniotic Wound Care Liquid for the Treatment of Non-Healing Venous Stasis Ulcers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04647240.
~13 spots leftby Apr 2025
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