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

Sponsor

Philozon Geradores de Ozonio LTDA (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01643967

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

14.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Other: sunflower oil Other: Ozone Therapy	Phase 3

Detailed 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

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Study Start Date :

Jun 1, 2012

Anticipated Primary Completion Date :

Dec 1, 2012

Anticipated Study Completion Date :

Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.
Active Comparator: 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. Other Names: Sunflower oil	Other: 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. Other Names: Philozon, MedPlus, Ozone Therapy

Arm

Intervention/Treatment

Experimental: 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.

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.

Active Comparator: sunflower oil

Other: 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.

Other Names:

Philozon, MedPlus, Ozone Therapy

Outcome Measures

Primary Outcome Measures

Evaluate the efficacy and safety of ozone released by the device Philozon Medplus in the treatment of patients with diabetic foot. [65 days]
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.

Secondary Outcome Measures

Evaluate the release of ozone in the environment by equipment MEdplus after insufflation rectal in patients with diabetic foot. [65 days]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Associação Hospitalar Beneficente São Vicente de Paulo	Passo Fundo	Rio Grande do Sul	Brazil	99010-080

Sponsors and Collaborators

Philozon Geradores de Ozonio LTDA

Investigators

Principal Investigator: Luiz L Pfluck, Investigator, Pronto Socorro de Fraturas
Principal Investigator: Marcelo C Burihan, Investigator, Hospital Santa Marcelina
Principal Investigator: Renato t Santos, Investigator, Associação Hospitalar Beneficente São Vicente de Paulo