Nonhealing wounds precede 80% of diabetes-related amputations, and BIOxHEAL is now cleared to test whether it can change that in a controlled trial.
Applied Biologics has
"Central IRB approval represents another significant milestone in the advancement of BIOxHEAL," said
The approval follows FDA's earlier clearance of the company's investigational new drug (IND) application.1 The phase 3 study is designed as a randomized, controlled, multicenter trial evaluating BIOxHEAL plus standard of care against standard of care alone in patients with nonhealing diabetic foot ulcers. With central IRB approval complete, Applied Biologics is now advancing clinical site activation, with patient enrollment expected to begin in the coming weeks. Britt said the company's focus is on "activating clinical sites and initiating patient enrollment as efficiently and responsibly as possible," and that it expects to provide updates as sites are activated and the first patients are enrolled.1
Diabetic foot ulcers affect approximately 18.6 million people worldwide each year, including 1.6 million in the United States, and precede an estimated 80% of lower-extremity amputations among people with diabetes.2 The lifetime risk of developing a diabetic foot ulcer among people with diabetes ranges from 19% to 34%, and ulcers that heal recur in roughly 65% of patients within 3 to 5 years. About half of diabetic foot ulcers become infected, and 15% to 20% of moderate to severe infections eventually lead to a lower-extremity amputation.2
People with a diabetic foot ulcer face a 5-year mortality rate of approximately 30%, rising to more than 70% for those who undergo a major amputation.2 Approximately half of people with a diabetic foot ulcer also have lower-extremity peripheral artery disease, which can complicate healing and treatment planning.2 Direct costs of treating diabetic foot ulcers in the US are estimated at $9 billion to $13 billion annually.2
Current standard of care for nonhealing diabetic foot ulcers typically includes wound debridement, offloading of pressure from the affected area, infection control, and management of underlying vascular disease,3 though many ulcers remain resistant to healing despite these measures, underscoring the rationale for evaluating adjunctive biologic therapies such as BIOxHEAL on top of standard of care rather than as a replacement for it. Britt noted in the release that "patients living with chronic diabetic foot ulcers face a substantial risk of infection, hospitalization, amputation, and diminished quality of life," and said the company believes these patients "deserve therapies developed through rigorous scientific research, pharmaceutical-quality manufacturing, and well-controlled clinical studies."1
BIOxHEAL is an
