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

NCT ID: NCT05974228

Last Updated: 2023-08-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2025-04-30

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.

Conditions

Chronic Wound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

Bioactive glass wound dressing

Bioactive glass wound dressing is a dressing covered on the wound bed

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yunfeng Li

UNKNOWN

Sponsor Role: collaborator

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Long Zhang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Long2023-CW-Bioglass

Identifier Type: -

Identifier Source: org_study_id