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

NCT06197412 | Recruiting Phase 4

• 1 other identifier: Long2023-YunnanBaiyao
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot Ulcer Treatment

Outcome Measures

Primary Outcomes (1)

• 2-week reduction rate of wound area

  Difference in wound area before and after treatment

  2 weeks

Secondary Outcomes (8)

• 2-week cure rate of wound

  2 weeks

• Local infection situation

  2 weeks

• Granulation tissue health status

  2 weeks

• Pain scoring

  2 weeks

• Microcirculation examination

  2 weeks

Study Arms (6)

control group 1

NO INTERVENTION

The optimal clinical treatment scheme was used to treat the wound of progressive infection period patients for 2 weeks

powder group 1

EXPERIMENTAL

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

Drug: Yunnan Baiyao

ointment group 1

EXPERIMENTAL

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

Drug: Yunnan Baiyao

control group 2

NO INTERVENTION

The optimal clinical treatment scheme was used to treat the wound of granulation period patients for 2 weeks

powder group 2

EXPERIMENTAL

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

Drug: Yunnan Baiyao

ointment group 2

EXPERIMENTAL

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

Drug: Yunnan Baiyao

Interventions

Yunnan Baiyao DRUG

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

ointment group 1; ointment group 2; powder group 1; powder group 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The age of the subjects is 18-80 years old;
• Diagnose diabetes according to WHO standards;
• Diagnosis of Diabetic foot;
• Confirmed as one of the stages of infection progression and granulation growth;
• Voluntarily participate in this study and sign an informed consent form.

You may not qualify if:

• Severe diseases such as acute myocardial infarction, heart failure, hepatitis, shock, and respiratory failure have not been corrected yet;
• Blood glucose is out of control, Glucose test#Fasting blood sugar\>15mmol /L, Glycated hemoglobin\>12%;
• There is active bleeding inside the wound, and routine basic treatment plans cannot be implemented;
• Serum albumin\<20g/L; Hemoglobin\<60g/L; Platelets\<50 × 109/L;
• Late stage subjects with malignant tumors;
• Active period of autoimmune diseases;
• Have a history of allergy to Yunnan Baiyao;
• The subject is unable to cooperate or has mental disorders;
• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University 3rd Hospital

Beijing, China

RECRUITING

MeSH Terms

Interventions

yunnan baiyao

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 17, 2023
• First Posted: January 9, 2024
• Study Start: December 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)