NCT01643967Unknown3 期
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.
Philozon Geradores de Ozonio LTDA2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年6月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Evaluate the efficacy and safety of ozone released by the device Philozon Medplus in the treatment of patients with diabetic foot.
研究概览
简要总结
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.
详细描述
- 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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Evaluate the efficacy and safety of ozone released by the device Philozon Medplus in the treatment of patients with diabetic foot.
时间窗: 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.
次要结局
- Evaluate the release of ozone in the environment by equipment MEdplus after insufflation rectal in patients with diabetic foot.(65 days)
研究者
研究点 (2)
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