Clinical evidence

GRAFIX PRIME Cryopreserved Placental Membrane: Significantly more patients with diabetic foot ulcers (DFUs) ≤5 cm2 achieved complete wound closure with reductions in estimated mean costs, compared with Dermagraft™36


Study overview

  • Prospective, randomized, single-blind, 9-week, head-to-head study at seven centers in the USA in patients with chronic DFUs (duration: 4-52 weeks; size: 1-15 cm2)
  • Patients received either GRAFIX PRIME Membrane (n=38) or Dermagraft (Organogenesis, Canton, MA, USA; n=37) weekly for up to eight applications or until complete wound closure, whichever was first
  • Standard of care was wound cleaning and debridement with offloading for plantar DFUs
  • More patients in the GRAFIX PRIME Membrane group had plantar wounds and wounds of longer duration, and fewer had lateral wounds, compared with the Dermagraft group (all p<0.05)
  • No significant difference in wound size (p=0.732)
  • Of the total population (n=75), 62 patients completed the study (per protocol population) and were included in the non-inferiority, clinical outcomes and cost analyses

Results

  • Patients achieving complete wound closure (primary endpoint) was similar (non-inferior) for GRAFIX PRIME Membrane and Dermagraft (Figure)
  • For GRAFIX PRIME Membrane compared with Dermagraft there were no significant differences in:
    • Wound area reduction ≥ 50%
    • Number of product applications
    • Mean percentage wound area reduction
  • For GRAFIX PRIME Membrane compared with Dermagraft in DFUs ≤ 5cm2:
    • Significantly more patients achieved complete wound closure at the end of treatment (p=0.0118; Figure)
    • Mean per patient product costs were significantly reduced
GRAFIX PRIME graph

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