search
Back to results

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

Primary Purpose

Diabetic Foot Treatment

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Yunnan Baiyao
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Treatment focused on measuring diabetic foot ; treatment

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    No Intervention

    Experimental

    Experimental

    No Intervention

    Experimental

    Experimental

    Arm Label

    control group 1

    powder group 1

    ointment group 1

    control group 2

    powder group 2

    ointment group 2

    Arm Description

    Outcomes

    Primary Outcome Measures

    2-week reduction rate of wound area
    Difference in wound area before and after treatment

    Secondary Outcome Measures

    Full Information

    First Posted
    September 25, 2023
    Last Updated
    September 25, 2023
    Sponsor
    Peking University Third Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT06062576
    Brief Title
    Clinical Observation and Mechanism Study of Yunnan Baiyao in Different Stages of Diabetic Foot
    Official Title
    Clinical Efficacy Observation and Mechanism Study of Yunnan Baiyao in Different Stages of Diabetic Foot
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 10, 2023 (Anticipated)
    Primary Completion Date
    June 30, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Peking University Third Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetic Foot Treatment
    Keywords
    diabetic foot ; treatment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    control group 1
    Arm Type
    No Intervention
    Arm Title
    powder group 1
    Arm Type
    Experimental
    Arm Title
    ointment group 1
    Arm Type
    Experimental
    Arm Title
    control group 2
    Arm Type
    No Intervention
    Arm Title
    powder group 2
    Arm Type
    Experimental
    Arm Title
    ointment group 2
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Yunnan Baiyao
    Intervention Description
    On the basis of the optimal clinical treatment scheme, Yunnan Baiyao powder or ointment was used to treat the wound for 2 weeks
    Primary Outcome Measure Information:
    Title
    2-week reduction rate of wound area
    Description
    Difference in wound area before and after treatment
    Time Frame
    2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs