Integra LifeSciences, a medical device company, has announced the completion of patient enrollment in a pivotal clinical trial designed to assess the safety and effectiveness of Integra dermal regeneration template in the treatment of diabetic foot ulcers.
Integra dermal regeneration template, an advanced bilayer skin replacement system, is developed for providing immediate wound closure and permanent regeneration of the dermis.
The randomized, controlled clinical trial will compare the safety and effectiveness of the Integra dermal regeneration template to the standard of care for the treatment of diabetic foot ulcers. This multi-center study enrolled 307 patients at 32 sites and all patients are followed for up to 28 weeks.
Patient follow-up is expected to complete in mid-2014. After completion of the patient follow-up, this data will form the foundation for submission for premarket approval from the US Food and Drug Administration.
Integra LifeSciences Extremity Reconstruction president Robert D Paltridge noted completion of patient enrollment in the Integra dermal regeneration template diabetic foot ulcer clinical trial is a major milestone for the company, and marks an important first step toward product commercialization.
"We hope to use the results from this study to receive the expanded indication, which will allow us to provide an additional treatment option to address the increasing prevalence of diabetic foot ulcers. We look forward to being able to better serve our customers and the diabetic population by providing clinically relevant, cost effective solutions," Paltridge added.