Dermagraft®, dermal substitute for treatment of diabetic foot ulcers
Dermagraft® is a cryopreserved human fibroblast-derived dermal substitute, composed of fibroblasts, extracellular matrix, and a bioabsorbable scaffold. Dermagraft is indicated for the treatment of >6-week-old full-thickness diabetic foot ulcers, which extend through the dermis, but without tendon, muscle, joint capsule, or bone exposure. Dermagraft should be used in conjunction with standard wound care regimens and in patients that have adequate blood supply to the involved foot.
A randomized controlled trial demonstrated a 64% relative increase in the number of patients achieving complete wound closure by 12 weeks following Dermagraft treatment [30.0% of Dermagraft-treated versus 18.3% of control patients (p=0.02)].
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Dermagraft is manufactured from human fibroblast cells derived from donated newborn foreskin tissue. The human fibroblasts are seeded onto a bioabsorbable polyglactin mesh scaffold, proliferate to fill the interstices of this scaffold and secrete human dermal collagen, matrix proteins, growth factors and cytokines. Dermagraft does not contain macrophages, lymphocytes, blood vessels, or hair follicles.
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Dermagraft®, dermal substitute for treatment of diabetic foot ulcers
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