A metabolically active human dermal replacement for the treatment of diabetic foot ulcers.

Tissue engineering, the science of growing living human tissues for transplantation, promises to revolutionize aspects of medical care. Ulcers of the skin of the feet of diabetic patients are a serious health problem and a major cause of amputations. Dermagraft, a tissue-engineered, living human dermal tissue, which provides normal growth factors and matrix proteins, has been implanted to replace a patients' destroyed dermises and heal these ulcers. Large-scale clinical studies and in vitro experiments have demonstrated the importance of controlling specific product parameters, especially the metabolic activity of the tissue, to provide, upon implantation into the wound bed, a living tissue that facilitates healing. Implanting tissue within a defined therapeutic range of metabolic activity dramatically improves healing of diabetic foot ulcers, with significantly more ulcers healed completely in a shorter time. In this new, rapidly moving science, such elucidation of the mechanism of action is vital to ensure that tissues will provide their intended benefit.

RCT Entities:   Population Interventions Outcomes