Clinical Excellence


Continuing a Heritage of Over Two Decades of Proven Clinical Excellence

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.

Study Objective

Evaluate the safety and efficacy of Integra Dermal Regeneration Template for the treatment of diabetic foot ulcers in comparison to standard of care.

Primary Endpoint

Secondary Endpoints

Safety End Point

Results

Complete Wound Closure

Incidence of complete wound closure was statistically greater for wounds treated with Omnigraft over SOC from weeks 5 to 16


Time to Closure

Wound Healing Rate

Median time to complete wound closure with Omnigraft was 43 days versus 78 for SOC

Patient Focused Outcomes

Number of Applications

  • Of those patients that healed
    • 92% did so in two or less applications
    • 72% did so in one application

Improved Quality of Life Metrics

  • Only randomized, controlled DFU trial to demonstrate significantly improved components of health-related quality of life metrics related to activities of daily living (e.g., walking, climbing stairs, and carrying groceries) and pain interfering with these activities which may decrease reliance on caregivers.

Safety

  • Treatment related adverse events (TRAE)* were similar in the active (Omnigraft) group (7/154 -4.5%) versus the control group (8/153 -5.2%)

    *TRAE in the Omnigraft group were diabetic foot infection, application-site cellulitis, cellulitis, infected skin ulcer, sepsis, application-site erythema, and excoriation.

Lower Total Cost of Treatment

With reduced number of applications, faster healing rates and fewer adverse events, Omnigraft may help to reduce total cost of treatment.

Wound Healing Progression


Initial wound, post-debridement, Omnigraft application

One week, four weeks, five weeks post-Omnigraft application

One month, two months, three months follow up after closure