Clinical trial NCT06197412: Multi-center Clinical Observation and Mechanism Study of Yunnan Baiyao in Different Stages of Diabetic Foot Ulcer
Official title: Multi-center Clinical Observation and Mechanism Study of Yunnan Baiyao in Different Stages of Diabetic Foot Ulcer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Diabetic Foot Ulcer Treatment
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2024-01-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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\&gt;15mmol /L, Glycated hemoglobin\&gt;12%;
3. There is active bleeding inside the wound, and routine basic treatment plans cannot be implemented;
4. Serum albumin\&lt;20g/L; Hemoglobin\&lt;60g/L; Platelets\&lt;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.

Primary outcomes:
measure: 2-week reduction rate of wound area
timeFrame: 2 weeks
Secondary outcomes:
measure: 2-week cure rate of wound
timeFrame: 2 weeks
measure: Local infection situation
timeFrame: 2 weeks
measure: Granulation tissue health status
timeFrame: 2 weeks
measure: Pain scoring
timeFrame: 2 weeks
measure: Microcirculation examination
timeFrame: 2 weeks
measure: Minor amputation rate
timeFrame: 3 weeks
measure: Major amputation rate
timeFrame: 3 weeks
measure: Mortality
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University 3rd Hospital
Study officials:
References: