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