Integra LifeSciences Holdings Corporation has completed its multicenter clinical trial evaluating the safety and effectiveness of the Integra Dermal Regeneration Template for the treatment of diabetic foot ulcers. It is also known as the DFU study. Integra Dermal Regeneration Template is a bi-layer skin replacement system designed to provide immediate wound closure and permanent regeneration of the dermis. The company conducted the clinical trial under an FDA Investigational Device Exemption (IDE).
“We closed out the DFU study and are in the process of evaluating all of our data. We believe that we achieved the key goals that we designed for the study, ” said Peter Arduini, Integra’s president and CEO. Arduini said that Integra is planning to submit the data from the trial to the FDA by the end of the year as well as submit it for publication in a peer-reviewed journal. He indicated that the firm anticipates commercialization of the DFU product by mid-2016.
The clinical trial enrolled 307 patients at 32 sites. Investigators followed up on all of the patients for up to 28 weeks. The primary endpoint of the study was the incidence of complete wound closure at 16 weeks. The secondary outcome measures included time to complete wound closure, incidence of recurrence, incidence of adverse events, and quality of life. Each of these was measured over 28 weeks.
An estimated 26 million people in the United States suffer from diabetes. Of those diagnosed, as many as 25% may experience a diabetic foot ulcer in their lifetime. The advanced wound care market is approximately $2.5 billion in the U.S, of which nearly $500 million is in cellular and tissue based products.
