Clinical Trial to Evaluate the Efficacy and Safety of the Use of Ozone Versus Sunflower Oil in Treating Diabetic Foot
NCT ID: NCT01643967
Last Updated: 2012-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
100 participants
INTERVENTIONAL
2012-06-30
2013-01-31
Brief Summary
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Detailed Description
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* 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).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Philozon Geradores de Ozonio LTDA
INDUSTRY
Responsible Party
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Principal Investigators
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Luiz L Pfluck, Investigator
Role: PRINCIPAL_INVESTIGATOR
Pronto Socorro de Fraturas
Marcelo C Burihan, Investigator
Role: PRINCIPAL_INVESTIGATOR
Hospital Santa Marcelina
Renato t Santos, Investigator
Role: PRINCIPAL_INVESTIGATOR
Associação Hospitalar Beneficente São Vicente de Paulo
Locations
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Associação Hospitalar Beneficente São Vicente de Paulo
Passo Fundo, Rio Grande do Sul, Brazil
Countries
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Central Contacts
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Facility Contacts
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Renato T Santos, Investigator
Role: primary
Keyla L Deucher, Coordinator
Role: backup
Other Identifiers
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PHI-OZO-01-10
Identifier Type: -
Identifier Source: org_study_id