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

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06062576
Enrollment
100
Registered
2023-10-02
Start date
2023-12-01
Completion date
2025-06-30
Last updated
2024-06-25

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

Conditions

Diabetic Foot, Therapeutics

Keywords

Diabetic Foot, Therapeutics

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.

Interventions

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

Sponsors

Peking University Third Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
2-week reduction rate of wound area2 weeksDifference in wound area before and after treatment

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026