(CS-155) Preliminary evaluation of human placental membrane products for chronic diabetic foot ulcers and venous leg ulcers: a qualitative case-series report from the BIOCAMP study

Gregory Bohn, MD – SerenaGroup, Inc.; Brianna Tramelli, BS – SerenaGroup, Inc.; Emily King, MS – SerenaGroup, Inc.; Dereck Shi, MS – SerenaGroup, Inc.; Ryan Breisinger, BS – SerenaGroup, Inc.

Introduction: Chronic diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) frequently demonstrate delayed or incomplete healing despite adherence to standard-of-care (SOC) practices, contributing to prolonged morbidity and increased risk of complications. Biologic wound coverings derived from human placental membranes (HPMs) provide structural scaffolding and bioactive properties that may support tissue repair. The BIOCAMP study evaluates HPMs as adjunctive therapies to SOC. This interim report integrates early case-series observations with preliminary aggregate findings.

Methods: Three patients with chronic DFUs were reviewed across multiple clinical sites. Eligible wounds measured >1.0 cm² and ≤20.0 cm² at baseline and demonstrated limited improvement following at least four weeks of SOC. Patients received one of the investigational HPMs, Dual Layer Amniotic Membrane (DLAM) or Tri-layer Amniotic Membrane (TLAM), in addition to SOC and were followed weekly for up to 12 weeks. The primary endpoint was complete wound closure at 12 weeks, defined as full re-epithelialization without drainage sustained for two consecutive visits and confirmed by blinded independent review. The secondary endpoint was percentage area reduction (PAR) from the initial treatment visit through the 12-week evaluation period.

Results: Across the three reviewed cases, wounds demonstrated consistent progression toward healing following treatment initiation. Qualitative assessment showed advancement in granulation tissue formation and wound margin reduction throughout the follow-up period. Complete wound closure was observed in all three cases. Favorable healing trends were observed across all evaluated placental membrane configurations, and no unexpected safety findings or product-related adverse events were reported.

Discussion: Interim findings from this three-patient BIOCAMP case series suggest that HPM products may support improved wound healing trajectories in chronic DFUs and VLUs that have not responded adequately to SOC alone. These early observations support continued enrollment and further analysis to better characterize clinical performance and durability of outcomes (Interim analysis will be run for the SAWC Spring conference.  Results to be determined).