Multicenter Hybrid Platform Trial Evaluating Amniotic Tissue Grafts in Chronic Wounds: A Real-World Evidence Protocol for Diabetic Foot and Venous Leg Ulcers
Summary: This protocol describes a multicenter hybrid platform trial using real-world evidence to evaluate amniotic tissue grafts for hard-to-heal DFUs and VLUs. Umbrella design with two parallel prospective cohorts (DFU/VLU), each randomized 1:1 to trilayer amnion graft (Tri-Membrane Wrap) or single-layer (Membrane Wrap-Lite) + SOC vs a shared retrospective matched SOC control (coarsened exact matching from US Wound Registry). Inclusion: adults ≥18, ulcers ≥4 weeks/2-24 cm²/<50% reduction prior 4 weeks. Sample: 55/group (165 total). Primary: complete wound closure at 12 weeks. Secondary: PAR at 4/8/12 weeks, time to closure. Prospective arms include WOUND-Q QoL/pain; safety monitoring. Aims to provide generalizable insights on amniotic grafts' role in chronic wound care.
Key Highlights:
- Design: Hybrid (prospective randomized + retrospective matched control).
- Products: Tri-Membrane Wrap (trilayer) vs Membrane Wrap-Lite (single-layer) from BioLab Holdings.
- Power: 80% for 30% healing difference (α=0.05).
- Patient-Centered: QoL/pain scores in prospective arms.
- Authors: Windy Cole, Marissa Carter, Caroline Fife, Marissa Docter.
Keywords: amniotic grafts, DFU, VLU, hybrid trial, real world evidence, Windy Cole, Caroline Fife