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CAMP RWE Trial: Amnion Grafts for Healing Hard-to-Heal Ulcers in RW Populations
Sponsor: Capsicure, LLC
Summary
CAMP RWE Trial: 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
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
165
Start Date
2025-10-01
Completion Date
2026-07-20
Last Updated
2025-10-22
Healthy Volunteers
No
Interventions
IP1: BioLab Membrane Wrap Lite IP2: BioLab Tri-Membrane Wrap
BioLab Membrane Wrap LiteTM is a human tissue allograft derived from the amniotic membrane that provides structural tissue for use as a wound and protectant covering. Membrane Wrap LiteTM is a single-layer human tissue allograft, containing solely the amnion layer of Amniotic Membrane \[Human Cellular and Tissue Based Product (HCT/P)\] for transplantation regulated by the US Food and Drug Administration under 21 CFR Part 1271.
IP2: BioLab Tri-Membrane Wrap
BioLab Tri-Membrane WrapTM is a human tissue allograft derived from the amniotic membrane that provides structural tissue for use as a wound and protectant covering. Tri-Membrane WrapTM is a triple-layered human tissue allograft, containing amnion-chorion-amnion layers \[Human Cellular and Tissue Based Product (HCT/P)\] for transplantation regulated by the US Food and Drug Administration under 21 CFR Part 1271.
Locations (7)
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
Hope Vascular and Podiatry
Houston, Texas, United States