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Amniotic Tissue Allograft

PalinGen Flow Amniotic Tissue Allograft for Chronic Leg Ulcers

Phase 2
Waitlist Available
Led By Joseph M Caporusso, D.P.M.
Research Sponsored by Amnio Technology, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up all adverse events (aes) and serious adverse events (saes) will be recorded from the time of signing of the informed consent form through week 64.
Awards & highlights

Study Summary

This trial will test a new treatment for chronic ulcers of the lower legs and feet to see if it is safe and effective.

Who is the study for?
This trial is for people with chronic ulcers on their lower legs or feet, which are at least 1.5 cm2 but no larger than 20 cm2 in size. Participants must have adequate blood flow to the area and controlled diabetes if applicable. They should not be bedridden, undergoing dialysis, pregnant, or have a recent history of deep vein thrombosis or certain treatments like immunosuppressants.Check my eligibility
What is being tested?
The study tests PalinGen Flow Amniotic Tissue Allograft's safety and early effectiveness in healing chronic leg and foot ulcers. It involves applying this tissue-based treatment to see if it helps wounds that haven't healed with standard care.See study design
What are the potential side effects?
While specific side effects aren't listed here, similar treatments may cause local reactions like redness or pain at the application site, infection risk increase due to open wounds being treated, and potential allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~all adverse events (aes) and serious adverse events (saes) will be recorded from the time of signing of the informed consent form through week 64.
This trial's timeline: 3 weeks for screening, Varies for treatment, and all adverse events (aes) and serious adverse events (saes) will be recorded from the time of signing of the informed consent form through week 64. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants in the PalinGen Flow plus SOC group versus SOC alone who achieve complete ulcer closure by Week 12.
Proportion of participants in the PalinGen Flow plus SOC group versus SOC alone with treatment-emergent adverse events (TEAEs)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PalinGen Flow Treatment plus SOCExperimental Treatment1 Intervention
Participants will receive wound size-dependent dose of PalinGen Flow liquid human amniotic tissue allograft by subcutaneous injection in addition to SOC.
Group II: Standard of Care (SOC)Active Control1 Intervention
Participants will receive SOC for chronic ulcers of the lower extremities.

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Who is running the clinical trial?

Amnio Technology, LLCLead Sponsor
Joseph M Caporusso, D.P.M.Principal InvestigatorFuturo Clinical Trials
~19 spots leftby Jun 2025
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