BioLab Holdings Inc, a US-based medical manufacturer specialising in wound healing and regenerative therapies, announce on Thursday the launch of a multicentre 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 company says that 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.

The interventional, comparative study will enrol 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.