Add Dermagraft weekly to conventional therapy for up to 8 applications1

  • In clinical studies evaluating Dermagraft for the treatment of ulcers in patients with diabetes, Dermagraft was applied weekly for up to a total of 8 applications over a 12-week period1,2
    • Once-weekly dosing of Dermagraft plus conventional therapy was informed by an exploratory dose-response study9
  • Diabetic foot ulcers must receive adequate sharp debridement, removing any necrotic or hyperkeratinized tissue, leaving a wound bed that meets the clinical criteria for skin grafting prior to application of Dermagraft (ie, clean, granulating wound bed)1
  • If extensive bleeding is observed after sharp debridement, the bleeding must be controlled before applying Dermagraft; no topical agents may be used to stop the bleeding1

Do not use any topical agents, cytotoxic cleansing solutions, or medications (eg, lotions, ointments, creams, or gels) on an ulcer being treated with Dermagraft as such preparations may cause reduced viability of Dermagraft.

 

Dermagraft has not been studied in patients receiving greater than 8 device applications.1

References: 1. DERMAGRAFT Directions for Use. Organogenesis. 2013. 2. Marston WA, et al. Diabetes Care. 2003;26(6):1701-1705. 3. Data on file. Shire Regenerative Medicine. 2013. 4. US Food and Drug Administration. Medical Devices. Premarket Approval. http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketapprovalpma/default.htm. Accessed February 6, 2013. 5. Roberts C, et al. Can J Plast Surg. 2002;10(suppl A):6A-13A. 6. Loots MAM, et al. J Invest Dermatol. 1998;111(5):850-857. 7. Margolis DJ, et al. Diabetes Care.1999;22(5):692-695. 8. Brem H, et al. Plast Reconstr Surg. 2006;117(7 suppl):S193-S209. 9. Gentzkow GD, et al. Diabetes Care. 1996;19(4):350-354.