BioLab Amnion Grafts for Chronic Wounds to Be Studied in AMNIOHEAL Trial

July 8, 2025—BioLab Holdings, Inc. recently announced the launch of a multicenter hybrid platform trial evaluating the clinical real-world effectiveness (RWE) of the company’s amnion-based wound care products in patients with hard-to-heal diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs).

According to the company, the interventional, comparative AMNIOHEAL RWE trial will evaluate trilayer and single-layer amnion grafts (BioLab’s Tri-Membrane Wrap and Membrane Wrap-Lite, respectively) in treating DFUs and VLUs. The prospective cohort treated with an amnion graft will be compared to a coarsened exact-matched retrospective control cohort.

As summarized in the press release, the study will enroll patients with chronic DFUs or VLUs that have persisted for at least 4 weeks and have not responded to standard of care (SOC) therapies (debridement, moisture balance, bacterial burden reduction, offloading, multilayer compression).

Patients in the study will receive either the Tri-Membrane Wrap or Membrane Wrap-Lite in addition to SOC. Outcomes will be compared to the control group treated with SOC alone.

BioLab stated that the trial’s hybrid design allows for the collection of prospective data while leveraging retrospective controls, enabling a broader and more diverse patient population than traditional randomized controlled trials. This approach is intended to yield insights into the RWE of BioLab’s products across the continuum of care, noted the company.