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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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100004428
Enrollment
Unknown
Registered
2021-02-10
Start date
2021-02-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot

Interventions

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Diabetic foot ulcer occurs again within a year;

Secondary

MeasureTime frame
Color ultrasound of lower extremity artery;Electromyography (EMG);Toe brachial index (TBI);Ankle brachial index (ABI);

Countries

China

Contacts

Public ContactLing Zhao

Guangdong Provincial Hospital of Traditional Chinese Medicine

18818866015@163.com+86 18818866015

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026