The FDA has approved Dermagraft®, a skin substitute used to help treat diabetic foot ulcers. It is made from human cells that have been placed on a dissolvable mesh material. When this "graft" is placed on the ulcer, the mesh is gradually absorbed and the human cells grow into place, replacing the damaged skin. The living cells in the graft produce many of the same proteins and growth factors found in healthy skin, which help to rebuild the damaged tissue in diabetic foot ulcers.
The new product is intended to help close ulcers that have been present for more than six weeks. It should not be used on infected ulcers, those with tunneling (sinus tracts), or those that involve tendon, muscle, joint capsule, or bone.
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Special issues - Foot care
Source: FDA. New Device Approval, Sept. 28, 2001.