Clinical results related to the use of the tissuetech autograft system in the treatment of diabetic foot ulceration

The application of tissue-engineering technology to wound healing has resulted in the development of a number of living skin equivalents, which have become a viable option in the treatment of chronic wounds. Unique among technologies of tissue engineering of skin is the TissueTech((R)) Autograft System (FIDIA Advanced Biopolymers, Abano Terme, Italy), as it incorporates an autologous dermal substitute (Hyalograft((R)) 3D, FIDIA Advanced Biopolymers) and an autologous epidermal replacement (Loserskin((R)), FIDIA Advanced Biopolymers). Each includes a matrix consisting of a hyaluronic acid ester (FIDIA Advanced Biopolymers) to promote cellular migration and graft take. Randomized clinical trials and extensive clinical experience have shown positive results in the treatment of diabetic foot ulcers using TTAS with high healing rates and excellent safety profile. A large retrospective analysis was conducted to assess the characteristics and outcomes of all chronic ulcers treated with TTAS from January 1997 to December 2000. Data deriving from the subgroup of the 401 diabetic foot ulcers are presented in this study. This group consisted of 104 neuropathic, 115 neuroischemic, 114 ischemic, and 58 post-surgical ulcers. Most of the ulcers treated were very large (85% with area greater than 5cm(2)) and full thickness or deep (85%), particularly in the neuroischemic and ischemic ulcer groups. The percentage of healed ulcers was high in all the subgroups (70.3% in the total diabetic foot population with 63.5% healed within 4 months), and the rate of recurrences was low, with 8.2 percent at a mean observation time from healing of 240 days in the total ulcer population. According to the available clinical evidence, TTAS can be effectively and safely used for the treatment of diabetic foot ulcers.