Additional trials of Dermagraft to start:
This article was originally published in Clinica
Executive Summary
The FDA has given Advanced Tissue Sciences (ATS) permission to begin additional trials of its Dermagraft skin replacement product for treating diabetic foot ulcers. The US agency told ATS in June that it must start a new trial of the skin before it can be approved (see Clinica No 812, p14). The new trial will include up to 30 centres and will involve 330 patients over 18 months. However, if an interim study of 180 treatments shows results equivalent to the previous PMA trial, the new trial could be stopped after one year.