Market Overview
Diabetic Foot Ulcers (DFU)
Diabetic foot ulcers (DFUs) are chronic sores that can develop on the foot or lower extremities of people with diabetes. DFUs often occur from complications of diabetes—specifically, peripheral neuropathy, a condition in which feeling, or sensation, is lost due to reduced blood flow to the lower extremities.1 Among people with diabetes, approximately 15% experience a DFU in their lifetime,1 and approximately 2.5% develop a DFU each year.2 If not properly treated, DFUs can result in serious complications.
References
- American Diabetes Association. Consensus Development Conference on Diabetic Foot Wound Care. Diabetes Care. 1999;22(8):1354-1360.
- Sheehan P, Jones P, Caselli A, Giurini JM, Veves A. Percent change in wound area of diabetic foot ulcers over a 4-week period is a robust predictor of complete healing 12-week prospective trial. Diabetes Care. 2003;26(6):1879-1882.
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.