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

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

Description

Eligibility

Age range

18+ years

Sex

All

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.

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