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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes, Foot Ulcer

Intervention / Treatment
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* Device: Sterile Wound Care Liquid Dressing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sterile Wound Care Liquid Dressing<br> | Device: Sterile Wound Care Liquid Dressing<br>* Sterile wound care liquid dressing is used in the wound treatment<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-week reduction rate of wound area |  | 2-week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-week wound healing rate |  | 2-week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes foot ulcer