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

NCT04667416 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2024-03-20

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Ulcer of Lower Extremity

Interventions

BIOLOGICAL

PalinGen Flow Amniotic Tissue Allograft

Participants will receive wound size-dependent dose of PalinGen Flow liquid human amniotic tissue allograft by subcutaneous injection in addition to SOC.

Sponsors & Collaborators

  • Amnio Technology, LLC

    lead INDUSTRY

Principal Investigators

  • Joseph M Caporusso, D.P.M. · Futuro Clinical Trials

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-19
Primary Completion
2024-03-31
Completion
2025-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04667416 on ClinicalTrials.gov