The FDA approved a new indication for the Integra Omnigraft Dermal Regeneration Matrix to treat certain diabetic foot ulcers.

Indications: Omnigraft is indicated for use in the treatment of partial and full-thickness diabetic foot ulcers that are greater than 6 weeks in duration. It should be used along with standard diabetic wound care.

Dosage and administration: The matrix device, which is made of silicone, cow collagen, and shark cartilage, is placed over the ulcer and provides an environment for new skin and tissue to regenerate and heal the wound.

Omnigraft should not be used in patients with allergies to bovine, collagen, or chondroitin. It should also not be used on infected wounds.

Efficacy and safety: In a study, 51% of patients treated with Omnigraft had healed ulcers after 16 weeks compared to 32% of those receiving usual care.

Side effects/risks: Adverse events include infections, increased pain, swelling, nausea, and new or worsening ulcers.

Citation:FDA approves Integra Omnigraft Dermal Regeneration Matrix to treat diabetic foot ulcers. FDA web site. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm480564.htm. Accessed January 13, 2015.

Integra Omnigraft Dermal Regeneration Matrix - Smart Solutions for Serious Wounds. Patient Guide to Healing Diabetic Foot Ulcers. FDA web site. http://www.accessdata.fda.gov/cdrh_docs/pdf/P900033S042c.pdf. Accessed January 13, 2015.