Human Placental Membrane Products for Foot and Leg Ulcers

(BIORESCUE Trial)

This trial tests human placental membrane products to heal foot and leg ulcers that resist healing on their own. Derived from the amniotic membrane, these products could provide a new treatment for diabetes-related ulcers. Individuals with diabetes and persistent foot or leg ulcers that did not heal in a previous study might be suitable for this trial. The study compares the new treatment to standard care to determine if it improves wound healing. As a Phase 4 trial, this research aims to understand how the already FDA-approved treatment can benefit more patients.

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking certain medications like immunosuppressants, cytotoxic chemotherapy, or hydroxyurea. It's best to discuss your current medications with the trial team to see if they might interfere with participation.

Research has shown that products like Tri-Membrane Wrap™ and Membrane Wrap™, made from human placental tissue, are well-tolerated for treating foot and leg ulcers. This tissue, known as the amniotic membrane, aids in wound healing.

Previous studies found these products safe for patients with ulcers that resist healing, including those caused by diabetes. Reports indicate that negative side effects are rare. Thorough sterilization removes potential contaminants, ensuring safety for wound use.

These treatments are undergoing a phase 4 trial, indicating strong evidence of their safety for human use. Phase 4 trials primarily confirm long-term effectiveness and safety, as these treatments have already passed earlier safety evaluations.

Researchers are excited about these human placental membrane products because they offer a novel approach to treating foot and leg ulcers. Unlike current standard treatments, which often involve dressings, creams, or surgical interventions, these products are derived from the human amniotic membrane. This source material is known for its regenerative properties, potentially enhancing healing by providing a natural scaffold for tissue repair. Additionally, these membrane wraps might reduce inflammation and infection risks more effectively than conventional methods. This unique approach could lead to faster and more complete healing for patients with diabetic foot ulcers (DFU) and venous leg ulcers (VLU).

This trial will evaluate various human placental membrane products for treating foot and leg ulcers. Studies have shown that products made from the human placental membrane can help treat stubborn diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). Participants in this trial may receive treatments like Tri-Membrane Wrap™ or Membrane Wrap™, which use human amniotic membrane known to aid in wound healing. Research indicates that these treatments, when combined with standard care, can improve healing rates more than standard care alone. Patients who have used these amnion-based products demonstrated promising results, with better wound closure. Overall, these treatments are already approved for similar conditions, making them a trusted option.¹³⁶⁷⁸