Diabetic Foot Ulcer Clinical Trial
Official title:
A Multicenter, Randomized, Controlled, Open Label Trial of DermACELL in Subjects With Chronic Wounds of the Lower Extremities
The study will compare treatment with DermACELL to conventional care in diabetic foot ulcers (DFU) and venous stasis ulcers (VSU).
This study is designed to demonstrate the effectiveness of DermACELL in the treatment of
chronic wounds of the lower extremities. DermACELL will be compared to conventional care in
both subjects with diabetic foot ulcers (DFU) and subjects with venous stasis ulcers (VSU).
In addition, DermACELL will be compared to an active comparator, GraftJacket, in subjects
with diabetic foot ulcers.
DermACELL and GraftJacket are both made from donated human skin (dermis). These products have
been processed so that cells are removed and bacteria and viruses are destroyed. This
processing provided a supporting structure, an acellular dermal matrix, into which cells can
migrate and divide during the wound healing process.
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