Study Will Assess Real-World Effectiveness of Tri-Layer and Single-Layer Amnion Grafts in Treating Diabetic Foot and Venous Leg Ulcers
PHOENIX, July 3, 2025 /PRNewswire/ — BioLab Holdings, Inc., a Phoenix-based medical manufacturer specializing in wound healing and regenerative therapies, is pleased to announce the launch of a multicenter hybrid platform trial evaluating the clinical effectiveness of its amnion-based wound care products in patients with hard-to-heal diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs).
The study, officially titled “AMNIOHEAL 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,” is designed to generate real-world evidence (RWE) on the performance of BioLab’s Tri-Membrane Wrap™ and Membrane Wrap – Lite™.
“This trial represents a significant step forward in our mission to bring innovative, evidence-based solutions to wound care,” said Dr. Marshall Medley, chief medical officer at BioLab. “By studying our products in real-world clinical settings, we aim to better understand their impact on healing outcomes for patients who need it most.”
The interventional, comparative study will enroll patients with chronic DFUs or VLUs that have persisted for at least four weeks and have not responded to standard of care (SOC) therapies. Participants will receive either the Tri-Membrane Wrap™ or Membrane Wrap – Lite™ in addition to SOC, which includes debridement, moisture balance, bacterial burden reduction, offloading and multilayer compression. Outcomes will be compared to a matched retrospective control group treated with SOC alone.
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 expected to yield insights into the real-world effectiveness of BioLab’s products across the continuum of care.
In addition to its clinical trials, BioLab continues to distinguish itself through its comprehensive provider support services, including application training, insurance verification, billing education and post-application assistance such as denied claims support and charity care coordination.
For more information on BioLab Holdings, Inc. and its suite of wound care products, visit biolabholdings.net.
About BioLab Holdings, Inc.
BioLab Holdings, Inc. is a Phoenix-based medical manufacturer focused on wound healing and regenerative medicine. Its product portfolio includes Membrane Wrap Lite™, Tri-Membrane Wrap™, Membrane Wrap™ and Membrane Wrap – Hydro™, all derived from human amniotic membrane. These minimally manipulated allografts are designed to preserve the tissue’s natural properties and support healing. BioLab is committed to delivering safe, high-quality products through innovation, education and exceptional customer service. Learn more at biolabholdings.net.
Contact: Kwyn Lowe
Phone: 406.314.5120
Email: [email protected]
SOURCE BioLab Sciences
