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Clinical Trial to Evaluate the Efficacy and Safety of the Use of Ozone Versus Sunflower Oil in Treating Diabetic Foot — PHIOZO0110  

Diabetes Mellitus Clinical Trial

Official title:
Clinical Trial, Open, Phase III, Multicenter, 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.

Clinical Trial Summary

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 Description

- 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01643967
Study type Interventional
Source Philozon Geradores de Ozonio LTDA
Contact Renato T Santos, Investigator
Phone 5554-3312-2099
Email renatotadeus@gmail.com
Status Recruiting
Phase Phase 3
Start date June 2012
Completion date January 2013
View Details
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