Platelet Rich Plasma (PRP): nuovo dispositivo medico per la cura delle ulcere in paziente diabetico

Hard to heal ulcers represent a significant complication in mellitus diabetes, and often lead to limb’s amputation. These are chronic ulcers that heavily compromise the patient’s quality of life, and represent a significant financial burden for the for National Health System. Traditional dressings used to treat diabetes related ulcers are not always resolutive, with variable recovery rates and high relapse frequency. For this reason, many innovative treatments have been developed, such as Platelet-rich plasma (PRP), whose working principle is based on the key role of platelet-derived growth factors in tissue regeneration. The purpose of this thesis has been to propose a bio-membrane derived from the combination of a hyaluronic acid matrix and an allogeneic PRP as a tool for treating diabetic ulcers. The use of an allogeneic product aims to overcome difficulties related to the autologous one, ensuring a therapeutic option to all the patients unable to benefit from their own-blood donation. The study has been divided into two phases: the in vitro bio-membrane set-up and a randomized double-blind clinical trial, in order to evaluate the effectiveness of the bio-membrane in cutaneous regeneration and the potential immunogenic power of the product. The bio-membrane has been characterized in the content and in the release kinetics of platelet growth factors and its biological activity has been tested in cell proliferation experiments on dermal fibroblasts. Data obtained in vitro show that a controlled platelet growth factor release occurs from the membrane: despite being moderate, it is nevertheless significantly able to induce proliferation of dermal fibroblasts in comparison to the control bio-membrane. This suggests that PRP combined with hyaluronic acid maintains its biological activity and that hyaluronic acid, in this formulation, acts as a vehicle for platelet growth factor delivery. The clinic trial has involved the use of the bio-membrane on 110 patients, divided into two groups: 55 of them treated with the bio-membrane containing PRP, and 55 treated with the bio-membrane containing physiological solution. The trial is still ongoing, and the future targets will be the evaluation of the bio-membrane regenerative effect and the immunological safety of the allogeneic product.