Effects of Autologous Keratinocyte Transplantation on the Quality of Life of Patients with Severe Chronic Leg Ulcers

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Abstract
Background: Chronic leg ulcers are painful and cost-intensive diseases associated with severe reductions of the patients’ quality of life (QoL). Autologous keratinocyte transplantation is a highly innovative treatment strategy that includes the in-vitro cultivation and transplantation of epidermal cells previously taken from the patient. Aim: Evaluation of the QoL of patients with severe and longterm chronic leg ulcers undergoing transplantation with cultured autologous keratinocytes (BioSeed(r)-S). Methods: Open pilot study including 21 patients with chronic leg ulcers of different origin (venous, diabetic, arterial). QoL was assessed before skin biopsy, before transplantation, and 2 and 6 weeks after transplantation using a Freiburg Life Quality Assessment (FLQA) module specific for chronic wounds. Clinical outcome was assessed by the degree of wound epithelization and by the reduction of ulcer diameter. Results: Compared to healthy subjects, the QoL scores before treatment were significantly reduced in all FLQA dimensions (physical complaints, everyday living, social life, emotional well-being, satisfaction and treatment). In the treatment course from the time before transplantation to 6 weeks after transplantation, there were significant improvements of QoL in all FLQA dimensions. Clinically, there was a mean increase of epithelization from 28.0 to 91.4% and a healing rate of 61.9% within 6 weeks. Conclusions: This pilot study indicates that the QoL of patients with severe leg ulcers can be significantly improved by autologous keratinocyte transplantation.

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