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Bioglass Wound Dressing in Treatment of Chronic Wound in Different Stage:a Randomized Controlled Trial

Primary Purpose

Chronic Wound

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bioactive glass wound dressing
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Wound focused on measuring Chronic wound, Bioactive glass

Eligibility Criteria

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

Inclusion Criteria: The patient is aged 18-80 years old; Ulcerative wounds; In the stage of stable necrosis or 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; Uncontrolled blood glucose, 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 < 20 g/L; Hemoglobin<60 g/L; Platelets<50 × 10^9/L; Spreading infection status, currently or about to be treated with antibiotics; Patients with advanced malignant tumors; Active period of autoimmune diseases; Previous allergies to bioactive glass ointment dressings (self originating); The patient 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

    Outcomes

    Primary Outcome Measures

    2-week reduction rate of wound area

    Secondary Outcome Measures

    2-week wound healing rate

    Full Information

    First Posted
    July 26, 2023
    Last Updated
    July 26, 2023
    Sponsor
    Peking University Third Hospital
    Collaborators
    Yunfeng Li
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05974228
    Brief Title
    Bioglass Wound Dressing in Treatment of Chronic Wound in Different Stage:a Randomized Controlled Trial
    Official Title
    Bioglass Wound Dressing in Treatment of Chronic Wound in Different Stage:a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2023 (Anticipated)
    Primary Completion Date
    May 31, 2024 (Anticipated)
    Study Completion Date
    April 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The goal of this randomized control trial is to test the efficacy and safety of a bioglass wound dressing in patients with chronic wound in different stages. The main question it aims to answer are: Whether the bioglass wound dressing have better efficacy and safety than blank control in treatment of chronic wound in necrosis stable stage? Whether the bioglass wound dressing have better efficacy and safety than blank control in treatment of chronic wound in granulation growth stage? Participants will be assigned with a 1:1 ratio into intervention group and control group. Participants of intervention group will receive bioglass wound dressing in addition with clinical optimal treatment plan. Participants of control group will only receive clinical optimal treatment plan.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Wound
    Keywords
    Chronic wound, Bioactive glass

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    Bioactive glass wound dressing
    Intervention Description
    Bioactive glass wound dressing is a dressing covered on the wound bed
    Primary Outcome Measure Information:
    Title
    2-week reduction rate of wound area
    Time Frame
    2-week
    Secondary Outcome Measure Information:
    Title
    2-week wound healing rate
    Time Frame
    2-week

    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 patient is aged 18-80 years old; Ulcerative wounds; In the stage of stable necrosis or 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; Uncontrolled blood glucose, 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 < 20 g/L; Hemoglobin<60 g/L; Platelets<50 × 10^9/L; Spreading infection status, currently or about to be treated with antibiotics; Patients with advanced malignant tumors; Active period of autoimmune diseases; Previous allergies to bioactive glass ointment dressings (self originating); The patient 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

    Bioglass Wound Dressing in Treatment of Chronic Wound in Different Stage:a Randomized Controlled Trial

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