For over 20 years medical professionals have trusted Integra’s Dermal Regeneration Matrix (DRM) Technology to treat the most challenging wounds. The DRM Technology has been evaluated in four clinical trials involving 444 patients and has a long history of safe, effective use treating patients with third degree burns, scar reconstruction, and acute and chronic wounds in the operating room. Now this powerful, proven solution is available in the outpatient setting to treat patients with diabetic foot ulcers (DFUs).
FOUNDER Study Demonstrates Omnigraft™ is Safe and Effective for the treatment of hard-to-heal diabetic foot ulcers (DFUs).
The FOUNDER Study was a multi-center, randomized, controlled parallel group clinical trial conducted under an Investigational Device Exemption.
Evaluate the safety and efficacy of Integra Dermal Regeneration Template for the treatment of diabetic foot ulcers in comparison to standard of care.
Incidence of complete wound closure was statistically greater for wounds treated with Omnigraft over SOC from weeks 5 to 16
Median time to complete wound closure with Omnigraft was 43 days versus 78 for SOC
*TRAE in the Omnigraft group were diabetic foot infection, application-site cellulitis, cellulitis, infected skin ulcer, sepsis, application-site erythema, and excoriation.
With reduced number of applications, faster healing rates and fewer adverse events, Omnigraft may help to reduce total cost of treatment.