To the Editor:

In reviewing the article, "The Edge Effect: Current Therapeutic Options to Advance the Wound Edge" in the February 2007 issue of Advances in Skin & Wound Care,1 we found a misstatement about Apligraf and its shelf life that we would like addressed. There also appears to be some confusion about indications for treatment versus the management of diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). On page 110 of the article, the statement is made that Apligraf must be applied within 5 days of delivery. Apligraf is guaranteed to be viable for 10 days from shipment and has a total 15-day shelf life from packaging.

Table 2 on page 102 is unclear about the indications for usage. Apligraf is indicated for the treatment of noninfected DFUs and VLUs supported by premarket approvals and randomized clinical trials. Apligraf is approved by the US Food and Drug Administration (FDA) for the treatment of DFUs and VLUs. Regranex and Dermagraft are only FDA-approved for the treatment of DFUs. Other products listed in Table 2 are 510k-approved for the management of wounds and have not undergone FDA review of clinical data from randomized clinical trials. The difference between wound management (noninteractive wound product) and wound treatment (interactive wound product) is essential to understanding current therapeutic options.

Evidence-based medicine with randomized clinical trials and outcomes-based studies are essential to the growing field of wound care.

Walter F. Keller, DO

Medical Marketing Specialist

Organogenesis

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