None listed
Conditions
Brief summary
The venous ulcer is a chronic skin lesion that does not tend to heal spontaneously, has no re epithelialization before 6 weeks and has a high frequency of recurrence. For this reason, research is studying new methods that can accelerate the healing process. In this scenario, the REAC technology is a regenerative medicine technology that can be useful in promoting the healing process. The purpose of this study is to verify whether the REAC treatment can speed up the healing process of venous leg ulcers, reducing pain and improving the patient's quality of life.
Interventions
The venous ulcer is a chronic skin lesion that does not tend to heal spontaneously, has no re epithelialization before 6 weeks and has a high frequency of recurrence. Since the venous ulcer is a chronic condition, characterized by the slow repair and by the tendency to recur, the goal of a therapy is to speed healing time, and improving the quality of life. In this study, we will use the Radio Electric Asymmetric Conveyer (REAC) technology, since it has already proved its efficacy in reparative and regenerative processes even at the cellular level. The REAC Tissue optimization - reparative (TO-RPR) treatment is administered by covering the area to be treated with a special laminar aluminum probe, which constitutes the asymmetric conveyer probe (ACP), connected to the REAC device. The REAC TO-RPR treatment used in this study has these features: radio frequency emission: 2.4 GHz; emission power <2mW; electric field intensity 0.1 volt/m +/- 20%; number of pulses 200 in 15 minutes of treatment; duty cycle 12.5%. The intervention will be administered by a medical doctor specialized in Phlebolymphology. This treatment will be administered once a week, according to the replacement of dressings. REAC TO-RPR is safe, painless, non-invasive and free of adverse effects. The REAC model device used in this study is B.E.N.E (ASMED, Florence, Italy). Patients will be treated also with standard dressing, that consists in cleansing with physiological solution, dressing with gauze impregnated with hyaluronic acid, overlapping 10 x10 folded gauze. After dressing, they will be treated with elastic compression, that consists of multi-layer compression bandaging with skinsaver bandage and cohesive overlaid. The treatments will be carried out until healing.
Sponsors
Study design
Eligibility
Inclusion criteria
Presence of venous ulcers, no signs of intolerance or allergy to constituents of the products used.
Exclusion criteria
age under 18 years; antibiotics, antifungal, antiviral or chemotherapy in place; pregnancy; immunosuppressive therapy ongoing or planned in the study period; surgeries scheduled in the study period; immune system diseases; life expectancy less than 6 months; systemic infections in place; moderate or severe cognitive impairment.