Diabetic foot ulcers (DFUs) are chronic wounds that can develop on the foot or lower extremities of people with diabetes.

The following clinical research studies and reviews document the incidence, outcomes and cost of DFUs, and the efficacy, safety and cost effectiveness of Dermagraft in improving the healing of DFUs. These are being provided for information/education purposes only and not for systematic re-distribution.

• Centers for Disease Control and Prevention. National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the United States, 2011. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, 2011.
• Lavery, et al. Diabetic foot syndrome. Evaluating the prevalence and incidence of foot pathology in Mexican Americans and non-Hispanic whites from a diabetes disease management cohort. Diabetes Care. 2006;26:1435-1438.
• Margolis, et al. Healing of diabetic neuropathic foot ulcers receiving standard treatment. A meta-analysis. Diabetes Care. 1999;22(5):692-695.
• Marston, et al. The efficacy and safety of Dermagraft in improving the healing of chronic diabetic foot ulcers: results of a prospective randomized trial. Diabetes Care. 2003;26(6):1701-5.
• Ramsey, et al. Incidence, outcomes and cost of foot ulcers in patients with diabetes. Diabetes Care. 1999;22:382-7. Conversion from 1995 to 2011 medical costs.
• Singh N, Armstrong DG, Lipsky BA. Preventing foot ulcers in patients with diabetes. JAMA. 2005;293(2):217-28.
• Armstrong DG, Wrobel J, Robbins JM. Guest Editorial: are diabetes-related wounds and amputations worse than cancer? Int Wound J. 2007;4:286-7.
• Moulik, et al. Amputation and mortality in new-onset diabetic foot ulcers stratified by etiology. Diabetes Care. 2003;26:491-4.
• 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.
• Consensus Development Conference on Diabetic Foot Wound Care. Diabetes Care. 1999;22(8):1354-1360.
• Centers for Disease Control and Prevention. History of foot ulcer among persons with diabetes – United States, 2000-2002. Atlanta, Ga: US Department of Health and Human Services; 2003. Accessed October 25, 2006.

About Advanced BioHealing, Inc.

Advanced BioHealing (ABH), a Shire company, specializes in the development and commercialization of life-altering regenerative medicine therapies. ABH currently manufactures and markets Dermagraft®, a bio-engineered skin substitute approved by the FDA for the treatment of diabetic foot ulcers. Dermagraft contains fibroblasts that secrete human dermal collagen, matrix proteins and growth factors.

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.