RecruitingNot ApplicableNCT07046767

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

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

Sponsor

Capsicure, LLC

Enrollment

165 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

Diabetic Foot Ulcer (DFU)Venous Leg Ulcer Wound; Foot

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying IP1: BioLab Membrane Wrap Lite IP2: BioLab Tri-Membrane Wrap and IP2: BioLab Tri-Membrane Wrap for people with diabetic foot ulcer (dfu), venous leg ulcer, and other related conditions. The study is currently recruiting participants at 7 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERIP1: 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.

OTHERIP2: 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.