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

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

Detailed Description

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 Hybrid prospective platform 2 arm, comparative, randomized multicenter study with a CSM matched retrospective control group Interventional comparative study * IP 1: BioLab Membrane Wrap Lite * IP2: BioLab Tri-Membrane Wrap Standard of care: Debridement, maintenance of proper moisture balance, reduction in bacterial burden, offloading and multilayer compression. Patients with nonhealing venous leg ulcerations or diabetic foot ulcers of at least 4-weeks duration that have failed to show 50% PAR with SOC therapies Patients receiving SOC therapies for hard-to-heal VLUs and/or DFUs To gather prospective real-world evidence (RWE) in both diabetic foot ulcers and venous leg ulcers increasing the understanding of treatment performance in everyday clinical settings, capturing insights from a more diverse patient population than traditional clinical trials. This information is vital for evaluating the effectiveness of innovative wound care strategies in practical, real-life scenarios To demonstrate the clinical effectiveness of IP1 and IP2 as an adjunct to standard of care in supporting wound healing compared to standard of care alone in venous leg ulcers and diabetic foot ulcers across the continuum of care.

Eligibility Criteria

Interventions