Amniotic Tissue Allograft for Chronic Leg Ulcers

Recruiting at 6 trial locations

Overseen By Sponsor Regulatory Affairs Manager

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Amnio Technology, LLC

Must be taking: Insulin, Oral medications

Must not be taking: Immunosuppressants, Chemotherapy, Antifungals, Antituberculosis

Disqualifiers: Infection, Dialysis, Cancer, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 64

Duration: 12 weeks

82 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called PalinGen Flow, derived from amniotic tissue, to determine its effectiveness in healing stubborn leg and foot ulcers. These ulcers, often caused by diabetes or poor blood flow, have not improved with standard care. Participants will receive either this new treatment alongside usual treatments or just the usual treatments to compare outcomes. Suitable candidates have had leg ulcers for at least four weeks that have not healed with regular treatment and have diabetes or circulation issues. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Is there any evidence suggesting that PalinGen Flow Amniotic Tissue Allograft is likely to be safe for humans?

Research has shown that PalinGen Flow, a treatment using amniotic tissue, is generally well-tolerated. One study found that these tissue transplants helped heal leg ulcers safely, with patients experiencing fewer side effects than those receiving standard care. Another study found that similar treatments improved wound healing and quality of life. Although there are no major safety concerns, mild side effects like redness or swelling might occur. As the trial is in an early phase, it focuses on ensuring the treatment's safety for participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for chronic leg ulcers?

Unlike the standard treatments for chronic leg ulcers, such as compression therapy and wound dressings, PalinGen Flow offers a unique approach by using liquid human amniotic tissue allograft. This treatment is exciting because it harnesses the regenerative properties of amniotic tissue, which can promote healing and tissue repair more effectively. Additionally, PalinGen Flow is administered through subcutaneous injection, potentially allowing for more targeted delivery to the wound site, which could accelerate healing compared to traditional methods.

What evidence suggests that PalinGen Flow might be an effective treatment for chronic leg ulcers?

Research has shown that PalinGen Flow, a treatment derived from amniotic tissue, may aid in healing chronic leg ulcers. In this trial, one group of participants will receive PalinGen Flow alongside the standard of care (SOC) for chronic ulcers of the lower extremities. Earlier studies have demonstrated that amniotic tissue improves ulcer healing compared to standard treatment alone. Patients treated with similar amniotic products healed faster and more completely. This indicates that adding PalinGen Flow to regular care could enhance healing for challenging leg ulcers. However, further research is necessary to confirm these initial findings. ^{1 2 3 6 7}

Who Is on the Research Team?

Joseph Caporusso, DPM

Principal Investigator

Futuro Clinical Trials

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Able to read, understand and sign the informed consent form (ICF)

≤20 cm2 in area

I'm sorry, but you haven't provided enough information about the criterion for subjects with DFU (Diabetic Foot Ulcers). Could you please provide more details?

Exclusion Criteria

Clinical evidence of ongoing infection and/or receipt of IV, oral, or topical antimicrobials at the Baseline Visit

Wheelchair bound or bed-ridden (ambulatory with assistance is acceptable)

Undergoing renal dialysis

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PalinGen Flow treatment plus standard of care for chronic ulcers

12 weeks

Visits at each study visit through end of treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks

Monitoring through Week 64

What Are the Treatments Tested in This Trial?

Interventions

• PalinGen Flow Amniotic Tissue Allograft

Trial Overview 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.

How Is the Trial Designed?

Group I: PalinGen Flow Treatment plus SOC Experimental Treatment 1 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 Control 1 Intervention

Participants will receive SOC for chronic ulcers of the lower extremities.

Who Is Running the Clinical Trial?

Amnio Technology, LLC

Lead Sponsor

Trials

1

Recruited

80+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9586828/

A Multicenter, Randomized, Controlled, Clinical Trial ... This randomized controlled trial evaluated the safety and effectiveness of weekly and biweekly applications of dehydrated human amnion and chorion allograft ...

2. withpower.com withpower.com/trial/phase-3-ulcer-2021-ebed0

Amniotic Tissue Allograft for Chronic Leg Ulcers 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 ...

3. ldh.la.gov ldh.la.gov/assets/medicaid/MCPP/1.5.24/222_UHC_Redline.pdf

Skin and Soft Tissue Substitutes (for Louisiana Only) Randomized controlled trials comparing AmnioFix with other skin substitutes and reporting on patient outcomes (e.g., complete wound healing, quality of life) ...

4. cms.gov cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=35041

LCD - Skin Substitute Grafts/Cellular and Tissue-Based ... An objective, non-invasive measure of perfusion/oxygenation to determine if there is adequate flow for wound healing is helpful in predicting ulcer healing and/ ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04667416

Safety and Preliminary Efficacy of PalinGen Flow Amniotic ... The purpose of this study is to assess the safety and preliminary efficacy of PalinGen® Flow for the treatment of chronic ulcers of the lower legs and feet.

6. uhcprovider.com uhcprovider.com/content/dam/provider/docs/public/policies/index/commercial/skin-soft-tissue-substitutes-08012025.pdf

Skin and Soft Tissue Substitutes Patients with chronic wounds, such as diabetic foot ulcers, pressure ulcers, and venous leg ulcers, experience loss of function, pain, wound ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12050365/

A Multicenter, Randomized, Controlled, Clinical Trial ... LPM and standard of care, significantly closed more venous leg ulcers and faster than standard of care alone and improved the quality of life for patients.