Adding Dermagraft to conventional therapy increases success in DFU healing1

  • In the Phase III pivotal trial, Dermagraft plus conventional therapy resulted in significantly more patients with DFUs >6 weeks duration achieving complete wound closure by 12 weeks vs conventional therapy alone (30% vs 18%, P=0.023)1,2
    • Patients reported being ambulatory an average of 8 hours per day1
    • Approximately half of patients had elevated HbA1C (>8.5%) and/or low albumin levels (2-4 g/dL)1

percent-of-patients-with-complete-healing-by-12-weeks

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.

Phase III pivotal trial: Dermagraft added to conventional therapy vs conventional therapy alone1,2

  • Description: A multicenter, randomized, single-blind, controlled, 12-week study in 314 patients comparing up to 8 weekly applications of Dermagraft plus conventional therapy to conventional therapy alone for the treatment of chronic DFUs >6 weeks duration
  • Objective: Determine the proportion of patients reaching complete wound closure by 12 weeks*
  • Patient population: Adults (≥18 years) with diabetes having a foot ulcer on the plantar surface of the forefoot (including toes) or heel that was between 1.0 and 20 cm2 at day 0 and that had been present ≥2 weeks
    • Key study exclusion criteria included the following: a) the Ankle-Arm Index on the study foot was <0.7; b) the study ulcer was over a Charcot deformity of the mid-foot; c) the study ulcer had sinus tracts or tunnels that could not be completely debrided; d) the study ulcer had increased or decreased in size by >50% during the 2-week screening period; e) the patient had a serum albumin <2.0 g/dL; f) the patient was receiving corticosteroids or immunosuppressive or cytotoxic agents; and g) the study ulcer showed clinical signs of infection1,2
  • Treatment: Except for the application of Dermagraft, treatment of study ulcers was identical for both groups: sharp debridement, saline-moistened gauze dressings, and pressure-reducing footwear
  • Off-loading: Total off-loading (eg, use of crutches, wheelchairs, or total contact casting) was not required

*A planned interim analysis showed a relationship between ulcer duration at screening and incidence of ulcer healing with Dermagraft. Consequently, a modified statistical plan specified that a) the effectiveness analyses would be based only on patients with ulcers >6 weeks duration at screening (N=245) and b) the primary endpoint would be analyzed using Bayesian statistical methods. The Bayesian analysis concluded that the probability that Dermagraft plus conventional therapy increased the chance of achieving wound closure in patients with ulcers >6 weeks duration over and above that of conventional therapy alone was 98.4%.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.