The wound will be treated either with the investigational formulation or the conventional treatment daily for 3 months.. After 15 minutes, the wound will be dressed with a fresh TegadermTM dressing. Monitoring of any adverse events will be performed on a daily basis. Once a week, the wound will be monitored by a physician: wound size will be determined and documented by photograph. Patients will be evaluated for pain sensation at the wound area and satisfaction by completing a QoL questionnaire Once a month during the experiment and one month after the end of treatment patients will undergo blood profile, blood glucose, and urine samples testing: at the initial and terminating visits. ECG and Ulcer culture will be also carried out. HbA1c, will be monitored once in 4 months