Multi-center Clinical Observation and Mechanism Study of Yunnan Baiyao in Different Stages of Diabetic Foot Ulcer

Peking University

Status and phase: Enrolling; Phase 4

Conditions: Diabetic Foot Ulcer Treatment

Treatments: Drug: Yunnan Baiyao

Study type: Interventional

Funder types: Other

Identifiers

NCT06197412

Long2023-YunnanBaiyao

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 6 patient groups

control group 1

No Intervention group

Description:

The optimal clinical treatment scheme was used to treat the wound of progressive infection period patients for 2 weeks

powder group 1

Experimental group

Description:

On the basis of the optimal clinical treatment scheme, Yunnan Baiyao powder was used to treat the wound of progressive infection period patients for 2 weeks

Treatment:

Drug: Yunnan Baiyao

ointment group 1

Experimental group

Description:

On the basis of the optimal clinical treatment scheme, Yunnan Baiyao ointment was used to treat the wound of progressive infection period patients for 2 weeks

Treatment:

Drug: Yunnan Baiyao

control group 2

No Intervention group

Description:

The optimal clinical treatment scheme was used to treat the wound of granulation period patients for 2 weeks

powder group 2

Experimental group

Description:

On the basis of the optimal clinical treatment scheme, Yunnan Baiyao powder was used to treat the wound of granulation period patients for 2 weeks

Treatment:

Drug: Yunnan Baiyao

ointment group 2

Experimental group

Description:

On the basis of the optimal clinical treatment scheme, Yunnan Baiyao ointment was used to treat the wound of granulation period patients for 2 weeks

Treatment:

Drug: Yunnan Baiyao