Clinical Observation and Mechanism Study of Yunnan Baiyao in Different Stages of Diabetic Foot

Diabetic Foot Clinical Trial

Official title:

Clinical Efficacy Observation and Mechanism Study of Yunnan Baiyao in Different Stages of Diabetic Foot

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06062576
• Other study ID #: Long2023-DFU-YunnanBaiyao
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: December 20, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Yunnan Baiyao has been treating all kinds of wounds for 120 years, but the evidence of Evidence-based medicine that is truly convincing is insufficient, making its best application method unclear. This study explored the possible indications and use methods of Yunnan Baiyao in different stages of Diabetic foot, and obtained Evidence-based medicine evidence of clinical efficacy. Obtain the discarded tissues of Diabetic foot patients in the treatment and control groups of Yunnan Baiyao after wound debridement, conduct Transcriptome (BulkRNA seq) analysis and detection on the wound tissues, and analyze the related signal pathways and functional genes with significant differences, to help clarify the possible treatment targets of Yunnan Baiyao.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. The age of the subjects is 18-80 years old;

2. Diagnose diabetes according to WHO standards;

3. Diagnosis of Diabetic foot;

4. Confirmed as one of the stages of infection progression and granulation growth;

5. Voluntarily participate in this study and sign an informed consent form.

Exclusion Criteria:

1. Severe diseases such as acute myocardial infarction, heart failure, hepatitis, shock, and respiratory failure have not been corrected yet;

2. Blood glucose is out of control, Glucose test#Fasting blood sugar>15mmol /L, Glycated hemoglobin>12%;

3. There is active bleeding inside the wound, and routine basic treatment plans cannot be implemented;

4. Serum albumin<20g/L; Hemoglobin<60g/L; Platelets<50 × 109/L;

5. Late stage subjects with malignant tumors;

6. Active period of autoimmune diseases;

7. Have a history of allergy to Yunnan Baiyao;

8. The subject is unable to cooperate or has mental disorders;

9. According to the judgment of the researcher, the subject has a clear reason that cannot be removed and affects wound healing, which is not suitable for this study or cannot comply with the requirements of this study.

Related Conditions & MeSH terms

• Diabetic Foot
• Therapeutics

Intervention

Drug:
• Yunnan Baiyao
On the basis of the optimal clinical treatment scheme, Yunnan Baiyao powder or ointment was used to treat the wound for 2 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-week reduction rate of wound area	Difference in wound area before and after treatment	2 weeks