Diabetic Foot Ulcer Treatment
Conditions
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
DRUGYunnan Baiyao
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
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
| Measure | Time frame | Description |
|---|---|---|
| 2-week reduction rate of wound area | 2 weeks | Difference in wound area before and after treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local infection situation | 2 weeks | No infection; local infection reduction; Local infection maintained;Local infection aggravated; Disseminated infection |
| Granulation tissue health status | 2 weeks | Healthy granulation, inflammatory granulation, infected granulation, edema granulation, aging granulation |
| Pain scoring | 2 weeks | visual analogue scale |
| 2-week cure rate of wound | 2 weeks | Proportion of healed wounds to total number of cases |
| Minor amputation rate | 3 weeks | distal ankle amputation |
| Major amputation rate | 3 weeks | leg and thigh amputations |
| Mortality | 3 weeks | the proportion of dead subjects to total subjects |
| Microcirculation examination | 2 weeks | ankle brachial index, ABI |
Countries
China
Outcome results
None listed