RPCEC00000423尚未招募3 期
Phase III clinical trial controlled with placebo, randomized, double-blind, for the evaluation of the efficacy and safety of Dermofural® 0.15% ointment as an antibacterial in patients adults with mild infection of diabetic foot ulcers. - EC III: Dermofural® - DF
Chemical Bioactive Center0 个研究点开始时间: 2023年4月24日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment
入排标准
- 年龄范围
- 19 year 至 one（—）
- 性别
- All
入选标准
- •1. Patients with a microbiological and clinical diagnosis of superficial DFU with mild infection, again diagnosed or previously treated.
- •2. UPD grade 1 according to Wagner's classification.
- •3. Neuropathic DFU.
- •4. Time elapsed since the last treatment indicated for DFU = 4 weeks.
- •5. Patients = 19 years of age.
- •6. Patients who express written voluntariness by signing the informed consent to participate in the research.
排除标准
- •1. Pregnancy, puerperium or breastfeeding.
- •2. History of allergy or hypersensitivity to Dermofural®/placebo or any of its components.
- •3. Chronic decompensated diseases that include, but are not limited to: diabetes mellitus, venous insufficiency, arterial hypertension, bronchial asthma, interstitial fibrosis, renal failure chronic, ischemic heart disease, symptomatic congestive heart failure, aortic stenosis, endocarditis, unstable angina pectoris, cardiac arrhythmia.
- •4. Patients who are being treated with immunotherapy or other oncological treatment or who are have received in the last three months prior to this study.
- •5. Autoimmune diseases.
- •6. History of psychiatric illnesses or mental incapacity that prevents you from expressing your voluntariness to participate in the study or makes its evaluation and treatment difficult.
- •7. Patient who has recently participated (1 month) or who is participating in another clinical trial at the time of selection.
- •8. Patients with active systemic or local infections that require the use of other agents antibacterial.
- •9. Patients who have received systemic antibacterial treatment in the 72 hours prior to moment of selection.
- •10. Patient who fails to comply with at least one of the daily treatments in the pre-inclusion period.
- •When a patient meets the 3rd exclusion criterion, a consultation may be scheduled within a period of time agreed between the doctor and the patient, to reevaluate his response to the treatment of the chronic disease in question.
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