Exploring Yunnan Baiyao for treating diabetic foot ulcers
Multi-center Clinical Observation and Mechanism Study of Yunnan Baiyao in Different Stages of Diabetic Foot Ulcer
PHASE4 · Peking University Third Hospital · NCT06197412
This study is testing whether Yunnan Baiyao, a traditional Chinese medicine, can help heal diabetic foot ulcers in patients at different stages of the condition.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Peking University Third Hospital (other) |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06197412 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of Yunnan Baiyao, a traditional Chinese medicine, in treating diabetic foot ulcers at various stages. It aims to gather evidence-based data on its efficacy by analyzing discarded tissues from patients undergoing treatment. The study will conduct transcriptome analysis to identify significant signal pathways and functional genes related to the treatment, thereby clarifying potential therapeutic targets. The goal is to enhance the understanding and application of Yunnan Baiyao in clinical settings.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 diagnosed with diabetes and diabetic foot ulcers at specific stages of infection and granulation.
Not a fit: Patients with severe uncontrolled diabetes, active bleeding, or other serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a validated treatment option for diabetic foot ulcers, improving patient outcomes.
How similar studies have performed: While Yunnan Baiyao has a long history of use, this study represents a novel approach to validating its efficacy through modern scientific methods.
Eligibility criteria
Show full inclusion / exclusion 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\>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.
Where this trial is running
Beijing
- Peking University 3rd Hospital — Beijing, China (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetic Foot Ulcer Treatment