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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 weeks3 visits

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.

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Amnio Technology, LLCLead Sponsor

Joseph M Caporusso, D.P.M.Principal InvestigatorFuturo Clinical Trials

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA given its seal of approval to PalinGen Flow Amniotic Tissue Allograft?

"While there is some data supporting the safety of PalinGen Flow Amniotic Tissue Allograft, it received a score of 2 because this is only based on Phase 2 trial results meaning that there is no evidence yet of efficacy."

Answered by AI

Is this clinical trial available in many hospitals within the city limits?

"This study is enrolling patients at 7 locations, which include the Center for Clinical Research in Castro Valley, Limb Preservation Platform in Carmichael, and Futuro Clinical Trials in Fresno."

Answered by AI

Are there any current vacancies in this research project for willing participants?

"From what is available on clinicaltrials.gov, it seems as though this study is still looking for more participants. The original posting was on 1/19/2021 with the most recent edit taking place on 1/5/2022."

Answered by AI

How many people fit the screening criteria for this clinical trial?

"Yes, the clinicaltrials.gov website currently has this trial listed as recruiting patients. The study was created on 19th January 2021 and was updated on 5th January 2022. They are looking for 81 people to participate at 7 different locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Preliminary Efficacy of PalinGen Flow Amniotic Tissue Allograft in Chronic Ulcers of the Lower Extremities

2021. "Safety and Preliminary Efficacy of PalinGen Flow Amniotic Tissue Allograft in Chronic Ulcers of the Lower Extremities". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04667416.