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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05974228
Other study ID # Long2023-CW-Bioglass
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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