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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
Must not have
Subject must not have another ulcer within 3 cm from the ulcer receiving investigational treatment
Must not have underlying osteomyelitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to weeks 4, 8 and 12
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.
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.
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have another ulcer within 3 cm of the one being treated.
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I do not have a bone infection.
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My ulcer does not show any bone, tendon, or ligament.
Select...
I do not have long-term muscle or bone problems that affect my ability to walk.
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I am not taking any oral steroids or getting steroid shots in my legs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to weeks 4, 8 and 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to weeks 4, 8 and 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety and tolerability
Secondary study objectives
Change in health-related quality of life
Change in pain
Total wound closure
+1 moreTrial 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
2 Previous Clinical Trials
85 Total Patients Enrolled
US Department of Veterans AffairsFED
875 Previous Clinical Trials
498,371 Total Patients Enrolled