Amnion Grafts for Foot Ulcers

(CAMP RWE Trial)

This trial aims to determine how two types of amnion grafts (a type of tissue wrap) aid in healing stubborn foot or leg ulcers. Participants will receive either a single-layer wrap (BioLab Membrane Wrap Lite) or a tri-layer wrap (BioLab Tri-Membrane Wrap) to assess which is more effective. The trial targets individuals with diabetic foot ulcers or venous leg ulcers that have shown minimal healing over four weeks and measure between 2 cm² and 25 cm². Participants should have had these ulcers for over four weeks with little visible healing. As an unphased trial, this study provides an opportunity to contribute to innovative research that could enhance healing options for chronic ulcers.

The trial information does not specify if you need to stop taking your current medications. However, if your wound is infected and requires antibiotics, you may not be eligible to participate.

Research shows that amnion grafts, such as the BioLab Membrane Wrap Lite and the BioLab Tri-Membrane Wrap, are undergoing safety testing for treating foot and leg ulcers. These treatments use layers of human amniotic membrane, a natural tissue that protects the baby in the womb, to aid in wound healing.

Studies have found that these amnion-based products are generally well-tolerated for diabetic foot ulcers and venous leg ulcers. The research available has reported no major safety concerns. Some minor side effects, like mild irritation or redness at the application site, might occur but are uncommon.

Researchers are excited about these amnion graft treatments for foot ulcers because they offer a novel approach by using biological materials to promote healing. Unlike traditional treatments that often rely on topical applications or surgical interventions, the BioLab Membrane Wrap Lite and BioLab Tri-Membrane Wrap employ advanced amniotic membranes, which are known for their regenerative properties. These membranes can enhance wound healing by providing essential growth factors and reducing inflammation. This unique mechanism could potentially accelerate recovery times and improve outcomes for patients with diabetic foot ulcers or venous leg ulcers compared to current standard care options.

Research has shown that amnion grafts, like the BioLab Membrane Wrap Lite and BioLab Tri-Membrane Wrap, studied in this trial, can aid in healing chronic wounds such as diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). Made from human placental membrane, these products have shown promise when used with standard care, improving healing outcomes. Studies indicate that these grafts may speed up healing and reduce wound size compared to standard treatment alone. Designed to repair tissue and reduce inflammation, these amnion-based products play a crucial role in healing stubborn wounds. Early results suggest these grafts could be a valuable option for individuals with hard-to-heal ulcers.¹⁴⁵⁶⁷