Clinical trial NCT01643967: Clinical Trial to Evaluate the Efficacy and Safety of the Use of Ozone Versus Sunflower Oil in Treating Diabetic Foot
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Diabetes Mellitus
Keywords: Ozone
Sunflower oil
diabetes Mellitus
Lead sponsor: Philozon Geradores de Ozonio LTDA
Sponsor class: INDUSTRY
First posted: 2012-07-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the efficacy and safety of ozone released by the device Philozon Medplus in the treatment of patients with diabetic foot.
timeFrame: 65 days
Secondary outcomes:
measure: Evaluate the release of ozone in the environment by equipment MEdplus after insufflation rectal in patients with diabetic foot.
timeFrame: 65 days
Other outcomes:
Locations:
city: Passo Fundo
country: Brazil
facility: Associação Hospitalar Beneficente São Vicente de Paulo
state: Rio Grande do Sul
Study officials:
affiliation: Pronto Socorro de Fraturas
name: Luiz L Pfluck, Investigator
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Santa Marcelina
name: Marcelo C Burihan, Investigator
role: PRINCIPAL_INVESTIGATOR
affiliation: Associação Hospitalar Beneficente São Vicente de Paulo
name: Renato t Santos, Investigator
role: PRINCIPAL_INVESTIGATOR
References: