CAMPR-II RWE TRIAL: A Saline-hydrated Allogeneic Dual-layer Amniotic Membrane Product or a Synthetic, Resorbable Polymeric Wound Matrix to a Coarsened Exact Matched Retrospective Control Cohort of Hard to Heal DFUs and VLUs

A multicenter hybrid platform trial comparing the effects of a prospective cohort treated with a saline-hydrated allogeneic dual-layer amniotic membrane product or a synthetic, resorbable polymeric wound matrix to a coarsened exact matched retrospective control cohort of patients with hardto-heal DFUs and VLUs Hybrid prospective platform 2 arm, comparative, randomized multicenter study with a CSM matched retrospective control group Study type Interventional comparative study Study product • IP 1: Membrane Wrap - Hydro™ • IP2: Microlyte® Matrix CSM matched cohort Standard of care: Debridement, maintenance of proper moisture balance, reduction in bacterial burden, offloading and multilayer compression. Prospective patient population 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 Control population Patients receiving SOC therapies for hard-to-heal VLUs and/or DFUs Retrospective data to be extracted retrospectively from the US Wound Registry: Demographic information Geographic location Number of wounds Frequency and number of wound care appointments Treatments received Number of infections Amputations Hospitalization Time to complete wound closure PROMs (if available) Study purpose 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 CAMPR-II Version 1.1 15 April 2026 7 vital for evaluating the effectiveness of innovative wound care strategies in practical, real-life scenarios Primary objective To demonstrate the clinical effectiveness of IP1 and IP2 as an adjunct to standard of care in supporting complete wound closure compared to standard of care alone in venous leg ulcers and diabetic foot ulcers across the continuum of care.