Applied Biologics Gains IRB Approval for Phase 3 BIOxHEAL Trial in Diabetic Foot Ulcers

Applied Biologics has received approval from the Advarra Institutional Review Board (IRB) for its randomized, controlled, multicenter phase 3 clinical trial evaluating BIOxHEAL for the treatment of nonhealing diabetic foot ulcers, a milestone the company said allows it to move toward activating clinical sites.¹

"Central IRB approval represents another significant milestone in the advancement of BIOxHEAL," said Edward Britt, CEO, Applied Biologics, in a company press release.¹ "Following FDA clearance of our phase 3 program, successful GMP [good manufacturing practice] manufacturing of our initial clinical lot, and now central IRB approval, we are transitioning into active clinical execution."

What does the phase 3 trial involve?

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

Why does nonhealing diabetic foot ulcer represent a significant unmet need?

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

What is BIOxHEAL?

BIOxHEAL is an investigational biologic being developed for the treatment of chronic wounds, including nonhealing diabetic foot ulcers.¹ It has not been approved by FDA, and its safety and effectiveness have not yet been established.¹ Applied Biologics said it expects to provide additional updates as clinical sites are activated, the first patients are enrolled, and the phase 3 clinical program continues to advance toward potential regulatory approval.¹

References

1. Applied Biologics. Applied Biologics receives central IRB approval for phase 3 BIOxHEAL clinical trial. News release. GlobeNewswire; August 5, 2026. Accessed August 5, 2026. https://www.globenewswire.com/news-release/2026/08/05/3339208/0/en/applied-biologics-receives-central-irb-approval-for-phase-3-bioxheal-clinical-trial.html
2. Armstrong DG, Tan TW, Boulton AJM, Bus SA. Diabetic foot ulcers: a review. JAMA. 2023;330(1):62-75. doi:10.1001/jama.2023.10578
3. Hingorani A, LaMuraglia GM, Henke P, et al. The management of diabetic foot: a clinical practice guideline by the Society for Vascular Surgery in collaboration with the American Podiatric Medical Association and the Society for Vascular Medicine. J Vasc Surg. 2016;63(2 suppl):3S-21S. doi:10.1016/j.jvs.2015.10.003