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FDA approves skin substitute for sealing diabetic foot wounds

Oct 30 (HeartCenterOnline) - The Food and Drug Administration (FDA) recently approved a skin substitute for use in the treatment of foot wounds common in diabetics. Called Dermagraft, the new product received FDA approval on September 28, 2001.

Dermagraft is a skin substitute designed to help close skin ulcers (slow-to-heal wounds) that can occur on the feet of diabetics. The product is made from a combination of human cells (fibroblasts) and a mesh material. When placed on the ulcer, the mesh is gradually absorbed, leaving the fibroblasts to replace and rebuild the damaged skin around the ulcer.

The FDA approved the Dermagraft to be used on:

* Full-thickness diabetic foot ulcers that have been present for more than six weeks.

* Deeper ulcers that involve blood vessels but do not involve tendon, muscle, joint capsule or bone.

According to the FDA, Dermagraft should not be used on infected ulcers or tunneling ulcers (wounds with sinus tracts). In addition, it should not be used in patients with allergies to products derived from cows because a bovine (cow-based) serum is used in the packaging for Dermagraft.

Diabetes is a disorder in the body's ability to use blood sugar (glucose). People with untreated diabetes may have dangerously high blood sugar levels. These high blood sugar levels can lead to a variety of symptoms (e.g., weakness) in the short-term, and serious consequences such as heart attack, stroke or other consequences of diabetes in the long-term.

More information can be found by visiting the HeartCenterOnline Diabetes Center.

Copyright 2001 HeartCenterOnline

 

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