Clinical Results Related to the Use of the TissueTech Autograft System in the Treatment of Diabetic Foot Ulceration

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Author(s): 
L. Uccioli, MD1 and the TissueTech Autograft System Italian Diabetic Foot Ulcer Study Group*

Introduction

Chronic wounds, which can include leg ulcers, pressure ulcers, and diabetic foot ulcers, are a major health burden and represent an expensive drain on healthcare resources.[1] Diabetic foot ulcers in particular represent a recurrent and expensive problem in terms of morbidity, mortality, and healthcare costs.[2,3] In recent years, standards of care have been accepted for diabetic foot ulcer treatment,[4,5] which include restoration of adequate vascular supply, treatment of infection, and offloading.[6] However, despite an optimum standard of care, many factors can affect wound healing and time of healing in the diabetic foot, such as patient’s age, gender, type and duration of diabetes, and ulcer size and duration.[7–9]

In the last few years, several new therapies have been developed in wound healing that take advantage of the advancements made in the understanding of wound physiology and the healing process.[10,11] Unique among these are treatments based on living skin equivalents.[12–27] These bioengineered tissues for replacement may be dermal, dermal and epidermal combinations, allograft, or autograft. It is thought that they exert their effects by providing an immediate skin coverage of the wound and by influencing the profile of growth factors and cytokines within the wound.[20]

Autologous tissue replacements have the distinct advantage of immunological compatibility. Furthermore, in some cases the scaffold on which the cells are grown may exert a positive effect on wound healing, as seen with the use hyaluronan-based scaffolds.[21,24,25] The TissueTech® Autograft System (TTAS) (FIDIA Advanced Biopolymers, Abano Terme, Italy) comprises a autologous dermal substitute (ADS) (Hyalograft® 3D, FIDIA Advanced Biopolymers) made of a resorbable three-dimensional matrix derived from hyaluronic acid (MHA) (HYAFF®, FIDIA Advanced Polymers)[25,28] onto which autologous fibroblasts (laboratory grown) are seeded and expanded, and autologous epidermal replacement (AER) (Laserskin®, FIDIA Advanced Polymers), a transparent biodegradable microperforated membrane of the three-dimensional matrix containing preconfluent autologous keratinocytes, applied seven days after the application of fibroblasts.[21,22,25,29]

The use of TTAS has shown positive results in the treatment of diabetic foot ulcers. An observational study on 60 patients with diabetic foot ulcers treated with ADS and AER showed a healing rate of 91.3 percent in a mean healing time of 72.7 ± 48.2 days without the occurrence of treatment-related side effects.[30] These findings have been recently confirmed by a randomized, controlled clinical trial where a 65-percent healing rate has been observed.[24] Other clinical experiences have shown the usefulness of the TTAS for the treatment of particularly difficult-to-heal diabetic ulcers.[22,31,32]

The clinical experience gathered on the use of TTAS led to the development of a protocol of use of this system on the treatment of diabetic foot ulcers,[33] which defines the indications, timing of application, and overall ulcer management, both at a local and at a general level. Based on this experience, a large retrospective, observational investigation has been recently undertaken in order to gain extensive data on the characteristics and outcomes of the chronic ulcers treated with the TTAS in everyday clinical practice from January 1997 to December 2000.[34] In the present study, the authors present in detail data on the diabetic foot ulcers, comprising 401 wounds in 346 patients.

Materials and Methods

This large retrospective, observational survey included all chronic ulcers of the foot affecting diabetic patients treated with the TTAS in the participating clinics between January 1, 1997, and December 31, 2000.

References: 

References

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