What is the mechanism of action of this treatment?

Common treatments for chronic leg ulcers, such as those involving bioactive components like PalinGen® Flow, work by promoting tissue repair and regeneration. These treatments often contain growth factors and cytokines found in amniotic fluid, which enhance cellular proliferation and differentiation, leading to faster wound healing. Additionally, they possess anti-inflammatory properties that reduce local inflammation, further aiding the healing process. For patients with chronic leg ulcers, these mechanisms are vital as they address the underlying issues of poor tissue regeneration and persistent inflammation, thereby improving healing outcomes and reducing the risk of complications.

What side effects are associated with this type of intervention?

Common treatments for chronic leg ulcers that promote tissue repair and regeneration, such as amniotic tissue allografts like PalinGen® Flow, skin grafts, and biologic therapies, generally have side effects including infection, pain at the application site, and potential allergic reactions. Skin grafts may also lead to complications such as graft failure, scarring, and donor site morbidity. Biologic therapies, while promising in enhancing healing, can sometimes cause immune reactions and require careful monitoring for adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments for chronic leg ulcers that focus on promoting tissue repair and regeneration. One notable example is the use of amniotic membrane products, such as EpiFix®, which contains dehydrated human amnion/chorion membrane to enhance wound healing. These products leverage the bioactive components in amniotic tissue to support tissue regeneration and repair. Other treatments include Apligraf®, a bioengineered skin substitute containing living cells, and Dermagraft®, which uses human fibroblast-derived dermal substitutes. These therapies aim to create a conducive environment for wound healing by providing essential growth factors and extracellular matrix components.

What other types of research exist?

Promising novel alternatives to PalinGen® Flow for chronic leg ulcers include angiogenic heparin mimetic nanofiber therapy, which supports the impaired healing process in diabetic wounds, and polydeoxyribonucleotide (PDRN)-delivering therapeutic hydrogel, which promotes cell proliferation, angiogenic growth factors, and new blood vessel formation, accelerating wound healing in diabetic models.

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Amniotic Tissue Allograft

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

No Placebo-Only Group

Summary

This trial is testing PalinGen® Flow, a special fluid from human tissue, to see if it can safely and effectively heal chronic ulcers on the lower legs and feet by providing essential growth factors and proteins.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for chronic leg ulcers, such as those involving bioactive components like PalinGen® Flow, work by promoting tissue repair and regeneration. These treatments often contain growth factors and cytokines found in amniotic fluid, which enhance cellular proliferation and differentiation, leading to faster wound healing. Additionally, they possess anti-inflammatory properties that reduce local inflammation, further aiding the healing process. For patients with chronic leg ulcers, these mechanisms are vital as they address the underlying issues of poor tissue regeneration and persistent inflammation, thereby improving healing outcomes and reducing the risk of complications.