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

NCT ID: NCT06062576

Last Updated: 2024-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2025-06-30

Brief Summary

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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

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Conditions

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Diabetic Foot Therapeutics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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control group 1

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

Group Type NO_INTERVENTION

No interventions assigned to this group

powder group 1

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

Group Type EXPERIMENTAL

Yunnan Baiyao

Intervention Type 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

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

Group Type EXPERIMENTAL

Yunnan Baiyao

Intervention Type DRUG

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

control group 2

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

Group Type NO_INTERVENTION

No interventions assigned to this group

powder group 2

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

Group Type EXPERIMENTAL

Yunnan Baiyao

Intervention Type 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 2

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

Group Type EXPERIMENTAL

Yunnan Baiyao

Intervention Type DRUG

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

Interventions

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Yunnan Baiyao

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Long Zhang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Peking University 3rd Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Long Zhang, Dr

Role: primary

Other Identifiers

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Long2023-DFU-YunnanBaiyao

Identifier Type: -

Identifier Source: org_study_id

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