Clinical Evaluation and Generalized Application of "Qing-Hua-Bu" Three Dynamic Sequential Therapy of Diabetic Ulcer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 150
- 主要终点
- Wound healing rate
研究概览
简要总结
This project is based on investigator team's ten year experience on diabetic ulcer and goes on further developing basic research and concluding clinical experience. The investigator team has recently developed "Remove stasis to generate granulation tissue" into "Remove slough to generate granulation tissue". Investigators have applied the principle of "Remove stasis" in the medium and later stage of treatment to make "Remove slough-Eliminate stasis-Generate granulation tissue" become the basic principle of three-stage sequential treatment. Investigators will further conclude Chinese medicine therapy in the stage of "Qing-Hua-Bu" and evaluate safety, applicability and availability of it. Therefore, the research can help improve clinical diagnosis and treatment technique and transfer the study result of Chinese medicine experience on diabetic ulcer.
详细描述
Aim: Under guidance of "Clear pus-Remove stasis-Supplement muscles" theory, to observe clinical effectiveness of dynamic Chinese external therapy of "Qing-Hua-Bu" in treating diabetic ulcer and partially explain potential wound healing mechanism.
Method: Clinical observation: To adopt the design method of open and parallel control test and include 150 diabetic ulcer patients. The treatment group was supplied with external clearing heat, removing stasis and supplementing deficiency Chinese medicine, while the control group was supplied with sulfadiazine silver cream, furacilin solution and bovine basic fibroblast growth factors (b-FGF) spray. To perform the dressing change for wound every day and persist in dressing change for two months. To record dynamic wound healing progress by digital camera. After finishing course, to compare wound healing, pus, exudate, granulation tissues and epithelial tissues and analyze these data by SPSS22.0.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •accord with standard of syndrome differentiation of traditional Chinese medicine and western medicine diagnostic criteria;
- •age between 18-65 years old, gender, ethnic unlimited;
- •agreed to participate in clinical trials can observe and cooperate with the visitor on schedule;
- •sign the informed consent form and mark the date;
- •If the patients are in the child-bearing period, they should accept the test of HCG and the result should be negative;
排除标准
- •systematic application of steroids or immunosuppressor within 2 weeks;
- •be allergic to any contents of known studied medicine;
- •experiment results that may influence patients' safety;
- •women within gestation period，suckling period or planning to gestation period;
- •patients with severe heart, liver or kidney diseases;
- •have received other studying medicine or taken part in other clinical experiments;
- •cannot cooperate with the study for any reasons,such as language understanding and not able to see the doctors;
- •other situations or diseases that researchers think may bring obvious risks to patients or interfere with the study results.
- •cancer ulcer; tuberculotic ulcer；radioactive ulcer
研究组 & 干预措施
External Chinese medicine
External Chinese medicine include 3 kinds of formula，including:
Qin, Hua and Bu will be applied to cover the participants' lesions in wet dressing form. Dosage form:5g/ml; frequency:qd; duration:2months.
干预措施: External Chinese medicine (Drug)
External Chinese medicine
External Chinese medicine include 3 kinds of formula，including:
Qin, Hua and Bu will be applied to cover the participants' lesions in wet dressing form. Dosage form:5g/ml; frequency:qd; duration:2months.
干预措施: External Western medicine (Drug)
External Western medicine
Ethacridine Lactate Solution, 1% Sulfadiazine Silver Cream and rb-bFGF will be applied to cover the participants' lesions. Dosage form:3g/ml; frequency:qd; duration: 2months.
干预措施: External Chinese medicine (Drug)
External Western medicine
Ethacridine Lactate Solution, 1% Sulfadiazine Silver Cream and rb-bFGF will be applied to cover the participants' lesions. Dosage form:3g/ml; frequency:qd; duration: 2months.
干预措施: External Western medicine (Drug)
结局指标
主要结局
Wound healing rate
时间窗: up to 56 days after treatment
To perform the dressing change for wound every day and persist in dressing change for two months. To record dynamic wound healing progress by digital camera. After finishing course, to compare wound healing, pus, exudate, granulation tissues and epithelial tissues and analyze these data by SPSS22.0.
次要结局
未报告次要终点