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

Diabetes Mellitus Clinical Trial

— PHIOZO0110  

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 Details — Status: Recruiting

Administrative data

• NCT number: NCT01643967
• Other study ID #: PHI-OZO-01-10
• Status: Recruiting
• Phase: Phase 3
• First received: June 29, 2012
• Last updated: July 16, 2012
• Start date: June 2012
• Est. completion date: January 2013

Study information

• Verified date: July 2012
• Source: Philozon Geradores de Ozonio LTDA
• Contact: Renato T Santos, Investigator
• Phone: 5554-3312-2099
• Email: renatotadeus[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Consent form signed;

• Patients with Diabetes Mellitus Type I or Type II trophic lesions presenting in the lower limbs;

• Injury whose largest diameter is less than 5 cm;

• Patients of both sexes, aged above 18 years;

• Heart rate 60 to 100 bpm.

Exclusion Criteria:

• Presence of severe septic conditions;

• IMC > 30;

• Presence of Lymphedema;

• Presence of trophic lesions in the lower limbs: exudative, traumatic and parasitic;

• Trophic lesions caused by venous disease requiring treatment;

• Hepatic or renal dysfunction;

• History of alcohol abuse and drugs in the last 6 months;

• Laboratory parameters:

• hemoglobin < 10 g/dl;

• Glycated hemoglobin > 9%;

• Diagnosis of hyperthyroidism (TSH < 0.50 µUI/mL, free T4 > 1.80 ng/dL);

• Deficit of Glucose 6 Phosphate Dehydrogenase (G6PD) > 20%;

• Use of immunosuppressive drugs or anticonvulsants;

• Pregnant woman or lactating;

• Any significant medical condition which in the opinion of the Investigator may bring risks to the patient;

• Known hypersensitivity to drugs and/or treatments to be used in the study;

• Inability to compliance with the protocol;

• Participation in another clinical trial for less than 30 days.

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Foot

Intervention

Other:
• sunflower oil
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.
• Ozone Therapy
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.

Locations

Country	Name	City	State
Brazil	Associação Hospitalar Beneficente São Vicente de Paulo	Passo Fundo	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Philozon Geradores de Ozonio LTDA

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate 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.	65 days	Yes
Secondary	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.	65 days	Yes