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RECRUITING
NCT07046767
NA

CAMP RWE Trial: Amnion Grafts for Healing Hard-to-Heal Ulcers in RW Populations

Sponsor: Capsicure, LLC

View on ClinicalTrials.gov

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

OTHER

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.

OTHER

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