ITMCTR2100004245招募中4 期
A randomized, double-blind multi-center, placebo, parallel design trial for evaluation of the efficacy and safety of Pien Tze Huang Capsule in the treatment of diabetic foot
适应症
试验速览
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
- 性别
- All
入选标准
- •1. Subjects aged 18-80 years, male or female;
- •2. Patients who meet the WHO (2019) diagnostic criteria for type 2 diabetes mellitus;
- •3. Subjects with Wagner grade 2-3 of diabetic foot;
- •4. Subjects with at least one subcutaneous foot ulcer as target ulcer;
- •5. Subjects with target ulcer surface area >= 2cm2 and < 10cm2;
- •6. Subjects with HbA1c <= 9% at the time of enrollment;
- •7. Subjects with abi (ankle brachial index) > 0.6 on the side of target ulcer;
- •8. Subjects who signed informed consent voluntarily.
排除标准
- •1. Patients with non-diabetic ulcer, such as rheumatic ulcer, radiation ulcer and vasculitis;
- •2. The number of ulcer wounds was more than 3 or the surface area of any ulcer wound was more than 10 cm2;
- •3. Patients with diabetic foot amputated stump wound as target ulcer wound only;
- •4. The target ulcer is located at the sole of the foot, and can not avoid being squeezed on the ground;
- •5. Patients with albumin < 30g / L;
- •6. Patients with severe clinical infection such as osteomyelitis or any symptoms or signs of systemic infection at the lesion site of ulcer;
- •7. Patients who still need to use antibiotics in follow-up treatment;
- •8. Patients with cancer, malignant tumor (ulcers over 3 months need biopsy to exclude malignant tumor), or severe primary diseases such as heart, cerebrovascular, liver, kidney and hematopoietic system (ALT or AST >= 2uln; New York Heart function grade IV; SCR >= 1.5uln); hemoglobin < 90g / L);
- •9. Subjects with mental disorders;
- •10. Pregnant, planned pregnant and lactating women;
- •11. Subjects with allergic constitution or known to be allergic to the components contained in the study drug;
- •12. Screening of patients who had been treated with EGF within 3 months before examination;
- •13. Screening of patients who had used traditional Chinese medicine or Chinese patent medicine in the treatment of diabetic foot within 2 days before examination (such as Mailuoning oral liquid, Longxuejie capsule, Tongxinluo capsule, Kangfuxin Liquid, etc.), whose main functions include: promoting muscle growth, anti-inflammatory, activating blood circulation and removing blood stasis, promoting granulation and epithelial tissue growth, etc.);
- •14. Screening of subjects who had participated in other clinical studies within 3 months before the examination;
- •15. Patients who are not suitable for this study according to the researcher's judgment.
研究者
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