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Diabetic Foot Ulcer

A prospective, randomized, controlled study comparing Apligraf® plus conventional therapy (debridement, saline dressings, total off-loading) to conventional therapy alone.

Study Design
Patient Demographics
  • 208 patients enrolled with diabetic foot ulcers
    • 67 with type 1 diabetes; 139 with type 2 diabetes; 2 not specified
  • Study excluded patients who exhibited rapid healing (>30% closure from day - 7 to day 0)
Ulcer Charactersitics
  • All patients had ulcers on the plantar surface of the foot
  • Mean ulcer size: 2.97 cm2 and 2.83 cm2 in the Apligraf and Control group, respectively
  • Mean duration: 12 months in the Apligraf group and 11 months in the Control group
Off-Loading
  • All patients used either crutches or a wheelchair for the first 6 weeks, followed by customized pressure-relieving footwear for at least 4 weeks postclosure