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A Multicenter Hybrid Platform Trial Comparing the Effects of a Prospective Cohort Treated With a Tri- Layer Amnion Graft or a Single Layer Amnion Graft to a Coarsened Exact Matched Retrospective Control Cohort of Patients With Hard-to-heal DFUs and VLUs
Conditions
Interventions
IP1: BioLab Membrane Wrap Lite IP2: BioLab Tri-Membrane Wrap
IP2: BioLab Tri-Membrane Wrap
Locations
7
United States
FOMAT Medical Research
Oxnard, California, United States
Solutions Medical Research
Coral Gables, Florida, United States
Nova Medical Services - Research Division LLC
Miami, Florida, United States
Indiana University Health Methodist Hospital
Indianapolis, Indiana, United States
St. Louis Foot and Ankle, LLC
St Louis, Missouri, United States
Jevlos Health, Inc
Syosset, New York, United States
Start Date
October 1, 2025
Primary Completion Date
July 20, 2026
Completion Date
July 20, 2026
Last Updated
October 22, 2025
NCT07541196
NCT06449638
NCT06811909
NCT07116876
NCT05489588
NCT06754735
Lead Sponsor
Capsicure, LLC
Collaborators
Data Source & Attribution
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