Chronic WoundNCT05974228
Bioglass Wound Dressing in Treatment of Chronic Wound in Different Stage：a Randomized Controlled Trial
A study testing Bioactive glass wound dressing in people with Chronic Wound, run by Peking University Third Hospital.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Wound
- What is being tested?
- Bioactive glass wound dressing
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
About this study
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
- Being tested
- Bioactive glass wound dressing
- Keywords
- Chronic wound, Bioactive glass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioactive glass wound dressingDevice
Bioactive glass wound dressing is a dressing covered on the wound bed
What is being measured
The primary outcome is the main question the study is designed to answer.
2-week reduction rate of wound area
Measured: 2-week
Secondary outcomes (1)
2-week wound healing rate
Measured: 2-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start1 Aug 2023 (estimated)
- Primary completion31 May 2024 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic WoundStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Yunfeng Li
- Responsible party
- Principal investigator, Long Zhang, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05974228
- Sponsor's protocol ID
- Long2023-CW-Bioglass
- Status last verified
- Jul 2023
- First submitted
- 26 Jul 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioglass Wound Dressing in Treatment of Chronic Wound in Different Stage：a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05974228
- Acronym / sponsor ID
- Long2023-CW-Bioglass
- Conditions
- Chronic Wound
- Keywords
- Chronic wound, Bioactive glass
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Yunfeng Li
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bioactive glass wound dressingBioactive glass wound dressing is a dressing covered on the wound bed | Device | – |
Primary outcome
2-week reduction rate of wound area
Time frame: 2-week
1 secondary outcome
2-week wound healing rate
Time frame: 2-week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Bioactive glass wound dressing in people with Chronic Wound, run by Peking University Third Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-week reduction rate of wound area (time frame: 2-week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023.