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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

82

Participants

Timeline

Start Date

January 19, 2021

Primary Completion Date

March 31, 2024

Study Completion Date

January 31, 2025

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.

Trial Locations (7)

76104

Acclaim Bone & Joint Institute and Plastic Surgery, Fort Worth

78501

Futuro Clinical Trials, McAllen

92083

ILD Research Center, Vista

93710

Limb Preservation Platform, Fresno

94115

Center for Clinical Research, San Francisco

94546

Center for Clinical Research, Castro Valley

95608

Center for Clinical Research, Carmichael

Sponsors
All Listed Sponsors
lead

Amnio Technology, LLC

INDUSTRY

NCT04667416 - Safety and Preliminary Efficacy of PalinGen Flow Amniotic Tissue Allograft in Chronic Ulcers of the Lower Extremities | Biotech Hunter | Biotech Hunter