BioLab Holdings, Inc., a medical manufacturer headquartered in Phoenix and specializing in regenerative medicine and wound healing solutions, has launched a new multicenter hybrid platform trial to assess the clinical effectiveness of its amnion-based wound care products. The trial focuses on treating patients with chronic, hard-to-heal diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs), marking a significant advancement in the company’s efforts to deliver real-world, evidence-based care solutions.
The “CAMP RWE Trial,” a clinical trial, will assess the efficacy of BioLab’s Membrane Wrap LiteTM and Tri-Membrane WrapTM. A prospective group receiving these grafts will be contrasted with a corresponding retrospective control group. The focus is on patients with hard-to-heal diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). This trial is a key step in validating the products in real-world clinical settings. These environments often present more complex challenges than controlled research conditions.
Participants in the study will be individuals suffering from DFUs or VLUs that have not improved despite at least four weeks of standard of care treatment. The trial will integrate the use of either the Tri-Membrane Wrap™ or Membrane Wrap – Lite™, in combination with standard therapies such as wound debridement, bacterial control, moisture management, offloading, and multilayer compression. Results will be assessed against a matched historical control group treated with standard of care alone.
This hybrid design offers the advantage of capturing both prospective clinical outcomes and retrospective comparisons, enabling the inclusion of a more varied and representative patient population. BioLab anticipates that this approach will provide deeper insights into the real-world efficacy of its wound care products and their role within comprehensive treatment strategies.
Alongside its research efforts, BioLab continues to support healthcare providers through services such as product application training, insurance assistance, and billing education. The company also offers help with denied claims and coordinates charitable care for patients in need.
BioLab Holdings, Inc. remains dedicated to advancing wound care through innovative technologies and high-quality, amnion-derived products. Its commitment to healing, education, and provider support continues to guide its growth in the field of regenerative medicine.
