Introduction

Biomedical device for the therapeutic treatment of ulcers or skin lesions, in particular diabetic ulcers. This device consists of a kit that includes the use of an electrostimulant device and a dressing containing a pharmaceutical composition that is applied simultaneously on the ulcer. Diabetic ulcers are characterized by a chronic inflammatory environment and an altered skin regeneration mechanism, which promotes bacterial proliferation and, consequently, the onset of infections difficult to eradicate. In addition, known drug treatments still have several limitations, such as low scalability, high cost of production, and various local side effects, including bacterial resistance.

Technical features

Device consisting of a kit comprising: electrostimulator device and a pharmaceutical composition dressing, consisting of a film containing a solution of povidone iodine (PVP-I) and sodium alginate (NaAlg). The electrostimulator device consists of at least two electrodes, intended to be arranged on diametrically opposite sides of the lesion at a fixed distance, and includes at least one electric pulse generator. These electrical impulses are organized in sequences with fixed values, according to FREMS technology, of amplitude, duration, frequency and/or waveform. FREMS technology has proven its efficacy in both treatment of neuropathic pain and in increasing blood flow in the anatomical areas where it is applied; also has the ability to increase the release of growth factors such as vascular endothelial growth factor (VEGF), valid for the treatment of diabetic ulcer. Finally, the electro-stimulator also includes a control unit which communicates with this electrical pulse generator and a control and/or data input interface.

Possible Applications

• Treatment of skin lesions
• Treatment of ulcers, specifically diabetic ulcers

Advantages

• Improved therapeutic efficacy
• Increased convenience of application in situ and/or replacement during the therapeutic process
• Relatively compact, easy to use, even independently from the patient himself, and relatively inexpensive, especially compared to currently known devices
• Medication naturally absorbable by the patient’s skin during treatment