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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Wound
• Intervention / Treatment: Device: Bioactive glass wound dressing

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Collaborators: Yunfeng Li

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: July 26, 2023
• First Submitted That Met QC Criteria: July 26, 2023
• First Posted (Actual): August 3, 2023

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Chronic wound; Bioactive glass
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: Long2023-CW-Bioglass

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No