Research & Development

Advanced BioHealing is conducting scientific research to enhance and support the manufacture and use of Dermagraft® for its FDA-approved indication for the treatment of diabetic foot ulcers.

Important Safety Information about Dermagraft®

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. Refer to Dermagraft Directions for Use for more information. Results may vary and not all patients will achieve complete wound closure with Dermagraft. In the pivotal trial, a 64% relative increase in complete wound closure was seen in the Dermagraft-treated patients; 30.0% of Dermagraft and 18.3% of conventional therapy patients achieved complete wound closure at 12 weeks. The most frequently reported adverse events experienced by patients in the Dermagraft group (terms ≥ 5%) included infection, accidental injury, skin dysfunction/blister, flu syndrome, osteomyelitis, surgeries involving study ulcer, wound enlargement/skin ulcer, cellulitis and peripheral edema/localized swelling. These adverse events were similar to those seen in the control group.