Efficacy and Safety of Oral Administration of Maiguan Fukang Tablets and External Washing of Tangbi Waixi Decoction in Reducing the Incidence of Ulcer Recurrence among Patients with Diabetic Foot Ulcers: a Protocol of a Randomized, Parallel-Arm, Controlled, Double-blind and Multicenter Clinical Trial

Guangdong Provincial Hospital of Chinese Medicine0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•1. Patients with diabetic foot diagnosis and Wagner grade 0 within three months of wound healing;
•2. Patients who meet the syndrome standard of blood stasis syndrome;
•3. Patients with fasting blood glucose less than 8 mmol / L, and 2 hours postprandial blood glucose less than 11.1 mol / L;
•4. Subjects aged between 18 and 75 years, male and female;
•5. Patients who voluntarily participated in the trial and signed the informed consent; The signing of informed consent conforms to the requirements of GCP.

•1. Patients with moderate to severe edema or skin disease of lower limbs;
•2. Diabetic ketoacidosis, hyperglycemic hyperosmolar syndrome, diabetic lactic acidosis and other acute complications, acute gout patients;
•3. Patients with cancer or heart, liver, kidney and other organ failure;
•4. Pregnant or lactating subjects or subjects with planned pregnancy in recent one year;
•5. Subjects who participated in other clinical studies in the past three months;
•6. Patients who can't understand the nature, scope and possible results of the study, or can't follow the doctor's advice;
•7. Mental patients;
•8. Subjects with allergic constitution, and those with allergic history of drugs, food or contact.

发起方

Guangdong Provincial Hospital of Chinese Medicine