BIOxHEAL for Foot Ulcers

(AB BIOH - DFU Trial)

This trial tests a new treatment called BIOxHEAL for diabetic foot ulcers that haven't healed with standard care. The researchers aim to determine if applying BIOxHEAL weekly, alongside usual treatment, helps ulcers close completely within 12 weeks. People with type 1 or type 2 diabetes who have had a foot ulcer for 4 to 52 weeks may qualify. Participants will be randomly assigned to receive either the new treatment plus standard care or just standard care. The trial seeks to improve healing for those with persistent foot ulcers. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Research shows that BIOxHEAL, a treatment derived from placental tissue, is under study for its potential to heal diabetic foot ulcers. Although complete safety information is still being collected, similar treatments have shown promise in past studies. For instance, Grafix, another product made from placental tissue, proved safe and effective for treating similar wounds. This suggests that treatments like BIOxHEAL might be well-tolerated. However, since BIOxHEAL remains in clinical trials, the FDA has not yet confirmed its safety and effectiveness. Participants in current studies are helping researchers gather more safety data.¹²³⁴⁵

Unlike the standard care for foot ulcers, which typically involves regular cleaning, dressing changes, and sometimes antibiotics, BIOxHEAL offers a novel approach by being applied topically to promote healing directly at the site. Researchers are excited about BIOxHEAL because it potentially speeds up the healing process by focusing on ulcer closure with its unique formulation. This targeted application might enhance recovery times and outcomes for patients, offering a promising alternative to existing treatments.

Research has shown that treatments like BIOxHEAL can help heal chronic wounds. In this trial, participants in the Sentinel Cohort and those randomized to receive BIOxHEAL will have it applied topically once weekly, alongside standard of care (SOC), to assess its effectiveness. Previous studies on similar treatments found that wounds remained closed for many patients after use. This suggests that BIOxHEAL might be more effective at healing diabetic foot ulcers than standard treatments alone. These treatments work by reducing stress in the body, aiding wound healing. Overall, evidence suggests that BIOxHEAL could improve healing for diabetic foot ulcers.⁶⁷⁸⁹¹⁰