Integra LifeSciences Holdings Corporation has announced the enrollment of 307 patients for ramdomized controlled clinical trial comparing the safety and effectiveness of
Integra(R) Dermal Regeneration Template, “an advanced bilayer skin replacement system designed to provide immediate wound closure and permanent skin regeneration, against standard of care for the treatment of diabetic foot ulcers.
Integra LifeSciences specializes in developing treatments for orthopedic extremity surgery, neurosurgery, spine surgery, and reconstructive and general surgery.
"Integra Dermal Regeneration Template has a long clinical history of success in burns and scar contracture release, and has the potential to help many people who are suffering with diabetic foot ulcers," stated lead clinical investigator Dr. Vickie Drive. "I look forward to seeing the results from the study, and am hopeful that we will have a new therapy to treat patients with difficult-to-heal wounds."
It is now estimated that 25% of the current 26 million people with diabetes in the US may suffer from disease related foot ulcers at some time during their lifetime. Diabetic foot ulcer is a major complication of diabetes mellitus, and is oftenj a precursor to 84% of allamputations of the lower leg due to the development of macro and micro vascular complications, including failure of the wounds to heal.
"Completion of patient enrollment in the Integra Dermal Regeneration Template diabetic foot ulcer clinical trial is a major milestone for Integra, and marks an important first step toward product commercialization," said Robert D. Paltridge, President, Extremity Reconstruction. "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."
The trials will take place at 32 sites, and all patients are followed for up to 28 weeks. Once patient follow-up is complete, this data will be sent to the FDA for eventual product approval.