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

NCT05974228 | Unknown DMC

• 1 other identifier: Long2023-CW-Bioglass
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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

Keywords

Chronic wound; Bioactive glass

Outcome Measures

Primary Outcomes (1)

• 2-week reduction rate of wound area

  2-week

Secondary Outcomes (1)

• 2-week wound healing rate

  2-week

Interventions

Bioactive glass wound dressing DEVICE

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient is aged 18-80 years old;
• Ulcerative wounds;
• In the stage of stable necrosis or granulation growth;
• Voluntarily participate in this study and sign an informed consent form

You may not qualify if:

• Severe diseases such as acute myocardial infarction, heart failure, hepatitis, shock, and respiratory failure 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;
• Serum albumin \< 20 g/L; Hemoglobin\<60 g/L; Platelets\<50 × 10\^9/L;
• Spreading infection status, currently or about to be treated with antibiotics;
• Patients with advanced malignant tumors;
• Active period of autoimmune diseases;
• Previous allergies to bioactive glass ointment dressings (self originating);
• The patient is unable to cooperate or has mental disorders;
• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Yunfeng Li: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 3, 2023
• Study Start: August 1, 2023
• Primary Completion: May 31, 2024
• Study Completion: April 30, 2025
• Last Updated: August 3, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share