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

Phase 4

Recruiting

• Conditions: Diabetic Foot Ulcer Treatment
• Interventions: Drug: Yunnan Baiyao

• Registration Number: NCT06197412
• Lead Sponsor: Peking University Third Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-01
• Study First Submitted: 2023-12-17
• Study First Submitted QC: 2024-01-06
• Study First Posted: 2024-01-09
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-30
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-12-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
powder group 1	Yunnan Baiyao	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
ointment group 1	Yunnan Baiyao	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
powder group 2	Yunnan Baiyao	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
ointment group 2	Yunnan Baiyao	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

Primary Outcome Measures

Name	Time	Method
2-week reduction rate of wound area	2 weeks	Difference in wound area before and after treatment

Secondary Outcome Measures

Name	Time	Method
2-week cure rate of wound	2 weeks	Proportion of healed wounds to total number of cases
Pain scoring	2 weeks	visual analogue scale
Microcirculation examination	2 weeks	ankle brachial index, ABI
Minor amputation rate	3 weeks	distal ankle amputation
Mortality	3 weeks	the proportion of dead subjects to total subjects
Granulation tissue health status	2 weeks	Healthy granulation, inflammatory granulation, infected granulation, edema granulation, aging granulation
Major amputation rate	3 weeks	leg and thigh amputations
Local infection situation	2 weeks	No infection; local infection reduction; Local infection maintained;Local infection aggravated; Disseminated infection

Trial Locations

Locations (1)

Peking University 3rd Hospital; 🇨🇳 Beijing, China