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

Last updated: June 30, 2024
Sponsor: Peking University Third Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Ulcers

Diabetes And Hypertension

Treatment

Yunnan Baiyao

Clinical Study ID

NCT06197412
Long2023-YunnanBaiyao
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 cannotbe 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 thatcannot be removed and affects wound healing, which is not suitable for this study orcannot comply with the requirements of this study.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Yunnan Baiyao
Phase: 4
Study Start date:
December 01, 2023
Estimated Completion Date:
March 31, 2026

Connect with a study center

  • Peking University 3rd Hospital

    Beijing,
    China

    Active - Recruiting

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