This is a open, phase III, multicenter, prospective, comparative, controlled, randomized clinical trial to evaluate the efficacy and safety of the use of ozone released by Philozon Medplus device versus conventional therapy in treating patients with diabetic foot.
* Clinical trial, open, phase III, multicenter, prospective, comparative, controlled, randomized to evaluate the efficacy and safety of the use of ozone released by Philozon Medplus device versus conventional therapy in treating patients with diabetic foot. * Primary Objective: evaluate the efficacy and safety of ozone released by the device Philozon Medplus in the treatment of patients with diabetic foot. * Secondary objective: evaluate ozone analyzer by environmental ozone Philozon Medplus released by the device in the clinical setting after using the device for rectal insufflation in a patient with diabetic foot. * Study population: Patients of both sexes, consisting of 100 patients over 18 years, patients with diabetic foot. * Treatment: 50 patients receive ozone therapy (topical and rectal insufflation of ozone). 50 patients will receive conventional treatment (Sunflower Oil).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
The research subjects allocated to this treatment arm will receive Sunflower Oil supplied by Philozon. Sunflower oil should be applied once daily for 60 days, it immediately after cleansing site where the lesion is present.
The research subject will receive topical and rectal insufflation of ozone three times a week on alternate days for two months or at least 12 sessions.
Associação Hospitalar Beneficente São Vicente de Paulo
Passo Fundo, Rio Grande do Sul, Brazil
RECRUITINGEvaluate the efficacy and safety of ozone released by the device Philozon Medplus in the treatment of patients with diabetic foot.
Evaluate the efficacy and safety of the release of ozone Medplus Philozon device in the treatment of patients with diabetic foot, through the clinical evaluation by the investigator based on the time needed for healing and decreasing the larger diameter of the lesion to be accompanied by image (photo), which register the size of the lesion in centimeters with a ruler.
Time frame: 65 days
Evaluate the release of ozone in the environment by equipment MEdplus after insufflation rectal in patients with diabetic foot.
Evaluate using ozone analyzer environmental ozone released by the device Philozon Medplus in the clinical setting after using the device for rectal insufflation in a patient with diabetic foot.
Time frame: 65 days
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