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Sterile Wound Care Liquid Dressing in Treatment of Diabetes Foot Ulcer: a Randomized Control Trial

Primary Purpose

Diabetes, Foot Ulcer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sterile Wound Care Liquid Dressing
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes focused on measuring Diabetes foot ulcer

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; Diagnose diabetes according to WHO standards; Diagnose diabetes ulcer; Confirmed as one of the stages of infection progression, necrosis stable, or granulation growth; The Pregnancy test of female patients with Fertility must be negative; Non eye damage to the wound surface and natural cavities such as the ear cavity, nasal cavity, and abdominal cavity; Voluntarily participate in this study and sign an informed consent form. Exclusion Criteria: Severe diseases such as acute myocardial infarction, heart failure, hepatitis, shock, respiratory failure, kidney failure, etc. 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;,4. Serum albumin < 20g/L; Hemoglobin < 60g/L; Platelets<50 × 10^9/L; 5. Patients with advanced malignant tumors; 6. Active period of autoimmune diseases; 7. Allergic history of sterile wound care liquid dressings; 8. The patient is unable to cooperate or has mental disorders; 9. Pregnant and lactating women;,10. Eye damage and natural cavities such as the ear, nose, and abdominal cavity; 11. Skin tumors; 12. Active skin diseases; 13. According to the judgment of the researchers, the patient has a clear and irremovable cause that 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 Type

    Experimental

    No Intervention

    Arm Label

    Sterile Wound Care Liquid Dressing

    Control

    Arm Description

    Outcomes

    Primary Outcome Measures

    2-week reduction rate of wound area

    Secondary Outcome Measures

    2-week wound healing rate

    Full Information

    First Posted
    July 27, 2023
    Last Updated
    July 27, 2023
    Sponsor
    Peking University Third Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05975827
    Brief Title
    Sterile Wound Care Liquid Dressing in Treatment of Diabetes Foot Ulcer: a Randomized Control Trial
    Official Title
    Sterile Wound Care Liquid Dressing in Treatment of Diabetes Foot Ulcer: a Randomized Control 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
    December 31, 2023 (Anticipated)
    Study Completion Date
    September 30, 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
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The goal of this randomized control trial is to test the efficacy and safety of the sterile wound care liquid dressing in patients with diabetes foot ulcer in different stages. The main question it aims to answer are: Whether the sterile wound care liquid dressing have better efficacy and safety than blank control in treatment of diabetes foot ulcer in infection progressive stage? Whether the sterile wound care liquid dressing have better efficacy and safety than blank control in treatment of diabetes foot ulcer in necrosis stable stage? Whether the sterile wound care liquid 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 sterile wound care liquid 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
    Diabetes, Foot Ulcer
    Keywords
    Diabetes foot ulcer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    600 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Sterile Wound Care Liquid Dressing
    Arm Type
    Experimental
    Arm Title
    Control
    Arm Type
    No Intervention
    Intervention Type
    Device
    Intervention Name(s)
    Sterile Wound Care Liquid Dressing
    Intervention Description
    Sterile wound care liquid dressing is used in the wound treatment
    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; Diagnose diabetes according to WHO standards; Diagnose diabetes ulcer; Confirmed as one of the stages of infection progression, necrosis stable, or granulation growth; The Pregnancy test of female patients with Fertility must be negative; Non eye damage to the wound surface and natural cavities such as the ear cavity, nasal cavity, and abdominal cavity; Voluntarily participate in this study and sign an informed consent form. Exclusion Criteria: Severe diseases such as acute myocardial infarction, heart failure, hepatitis, shock, respiratory failure, kidney failure, etc. 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;,4. Serum albumin < 20g/L; Hemoglobin < 60g/L; Platelets<50 × 10^9/L; 5. Patients with advanced malignant tumors; 6. Active period of autoimmune diseases; 7. Allergic history of sterile wound care liquid dressings; 8. The patient is unable to cooperate or has mental disorders; 9. Pregnant and lactating women;,10. Eye damage and natural cavities such as the ear, nose, and abdominal cavity; 11. Skin tumors; 12. Active skin diseases; 13. According to the judgment of the researchers, the patient has a clear and irremovable cause that affects wound healing, which is not suitable for this study or cannot comply with the requirements of this study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Long Zhang, MD
    Phone
    +86 010-82266699
    Email
    longzh2000@163.com

    12. IPD Sharing Statement

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    Sterile Wound Care Liquid Dressing in Treatment of Diabetes Foot Ulcer: a Randomized Control Trial

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