The United States Food and Drug Administration (USFDA) has approved the PMA supplement for Integra Dermal Regeneration Template (IRDT) diabetic foot ulcer treatment based on FOUNDER study. IRDT was developed by Integra LifeSciences Holdings Corporation.
Randomized, controlled, parallel group study was conducted to demonstrate the safety and efficacy in the target group patients. The primary endpoint of the study was complete wound closure at 16 weeks.
After 29 weeks of follow-up, visible improvement with complete wound closure was observed in 59% of the treated patients compared to conventional treatment receivers.