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

Phase 1

Recruiting

• Conditions: Diabetic Foot; BD54

• Registration Number: ITMCTR2100004428
• Lead Sponsor: Guangdong Provincial Hospital of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diabetic foot ulcer occurs again within a year;

Secondary Outcome Measures

Name	Time	Method
Color ultrasound of lower extremity artery;Electromyography (EMG);Toe brachial index (TBI);Ankle brachial index (ABI);