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

Chronic Wound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05974228
• Other study ID #: Long2023-CW-Bioglass
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: April 30, 2025

Study information

• Verified date: July 2023
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: April 30, 2025
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. The patient is aged 18-80 years old;

2. Ulcerative wounds;

3. In the stage of stable necrosis or granulation growth;

4. Voluntarily participate in this study and sign an informed consent form

Exclusion Criteria:

1. Severe diseases such as acute myocardial infarction, heart failure, hepatitis, shock, and respiratory failure have not been corrected yet;

2. Uncontrolled blood glucose, Glucose test#Fasting blood sugar>15mmol/L, Glycated hemoglobin>12%;

3. There is active bleeding inside the wound, and routine basic treatment plans cannot be implemented;

4. Serum albumin < 20 g/L; Hemoglobin<60 g/L; Platelets<50 × 10^9/L;

5. Spreading infection status, currently or about to be treated with antibiotics;

6. Patients with advanced malignant tumors;

7. Active period of autoimmune diseases;

8. Previous allergies to bioactive glass ointment dressings (self originating);

9. The patient is unable to cooperate or has mental disorders;

10. 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.

Related Conditions & MeSH terms

• Chronic Wound
• Wounds and Injuries

Intervention

Device:
• Bioactive glass wound dressing
Bioactive glass wound dressing is a dressing covered on the wound bed

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Peking University Third Hospital	Yunfeng Li

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-week reduction rate of wound area		2-week
Secondary	2-week wound healing rate		2-week