Important Safety Information
Intended Use/Indications Dermagraft is indicated for use in the treatment of full-thickness diabetic foot ulcers greater than 6 weeks duration, which extend through the dermis, but without tendon, muscle, joint capsule, or bone exposure. Dermagraft should be used in conjunction with standard wound care regimens and in patients that have adequate blood supply to the involved foot.
Contraindications Dermagraft should not be used on ulcers that have signs of clinical infection, sinus tracts (narrow passages extending from the wound), or exposed tendon, muscle, joint capsule, or bone. Dermagraft should not be used in patients with known allergy to bovine (cow) products, as it may contain small amounts of bovine proteins from the manufacturing and storage solutions.
The most frequently reported adverse events (> 5%) experienced by Dermagraft-treated patients in the pivotal trial were infection, accidental injury, skin dysfunction/blister, flu syndrome, osteomyelitis, surgeries involving study ulcer, wound enlargement/skin ulcer, cellulitis, and peripheral edema/localized swelling.
Click here to view full safety information in the Dermagraft Directions for Use
