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

Trial Summary

What is the purpose of this trial?

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.

Research Team

Joseph Caporusso, DPM

Principal Investigator

Futuro Clinical Trials

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+