ITMCTR2000004197招募中4 期
Evidence-based Appraisal Research of Traditional Chinese External Tazi Therapy with Fufang Huangbai Ye to Control Diabetic Foot Ulcer with Drug-resistant Bacteria
Dongzhimen Hospital, Beijing University of Chinese Medicine0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 75(—)
- 性别
- All
入选标准
- •1. Patients meeting the diagnostic criteria of diabetic foot;
- •2. Patients with IDSA grade 2;
- •3. Culture confirmed the bacteriological basis, and the wound was infected by drug-resistant bacteria;
- •4. Patients with HbA1c <= 8%;
- •5. Patients between 18 and 75 years old, male or female;
- •6. Patients with ABI >= 0.4;
- •7. Patients with wound area between 1 cm x 1cm and 10 cm x 10cm;
- •8. Patients who voluntarily participated in the trial and signed the informed consent.
排除标准
- •1. Patients allergic to compound Phellodendron solution and silver ion antibacterial dressing;
- •2. Patients who used antibiotics in any way within one week before treatment;
- •3. Serious heart, liver and kidney dysfunction, which seriously affect the safety and treatment of the subjects, should be ruled out by the researchers;
- •4. Patients with foot ulcer caused by venous, tumor, radiation, simple arterial and other non-diabetic reasons.
- •5. Patients with serum albumin < 25g / L;
- •6. Patients with hemoglobin < 90g / L;
- •7. Patients whose platelets are lower than the lower limit of normal value;
- •8. Subjects with pregnancy or birth planning, or pregnant or lactating women;
- •9. Patients with cognitive impairment can not give full informed consent;
- •10. Patients with allergic constitution or known hypersensitivity to the components of test drug and control drug;
- •11. Patients who participated in other clinical trials in recent one month;
- •12. According to the judgment of the researcher, the patient was unable to complete the study or comply with the requirements of the study.
研究者
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