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Diabetic Foot Ulcer

Incidence of the Most Common* Adverse Events

  Apligraf® (n=112) Control (n=96)
At the Study Ulcer Site
Suspected wound infection 12 (10.7%) 13 (13.5%)
Cellulitis 10 (8.9%) 8 (8.3%)
Osteomyelitis 3 (2.7%) 10 (10.4%)
Not at the Study Ulcer Site
Neuropathic ulcer† 19 (17.0%) 9 (9.4%)
Suspected wound infection 15 (13.4%) 7 (7.3%)
Nonneuropathic skin alteration‡ 13 (11.6%) 11 (11.5%)
Cellulitis 11 (9.8%) 4 (4.2%)
Osteomyelitis 10 (8.9%) 3 (3.1%)
Peripheral edema 4 (3.6%) 11 (11.5%)

*Occurring in 10 or more patients.

†New ulceration.

‡Ulcer skin (erosions, fissures, lacerations, excoriations, and abrasions).

Additional safety parameters (hospitalizations, sepsis, life-threatening adverse events, and death) were comparable.

At sites other than the study ulcer, a total of 84 and 48 wound-related adverse events occurred in the Apligraf and control groups, respectively.

The Use of Apligraf is Supported by Experience
Well tolerated in over 80,000 patient applications.1

Reference:
¹Data on file at Organogenesis Inc.