Chronic WoundNCT07235254
A RCT of Moist Ag Dressing in Chronic Wound
A study testing Ag foam dressing named MepilexAg and Dry Ag dressing in people with Chronic Wound and Hard to Heal Wounds, run by Peking University Third Hospital at 1 site in China.
Trial summary
This study aims to explore the differences in efficacy and cost-effectiveness between self-adhesive soft polysilicone silver ion foam dressings and traditional silver dressings in local infected wounds through a prospective randomized controlled study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Wound, Hard to Heal Wounds, Dressing
- What is being tested?
- Ag foam dressing named MepilexAg and Dry Ag dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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's age ranges from 18 to 80 years old.
- According to the IWII wound infection staging, infected wounds are classified as local infections*.
- The wound type is ulcer, with an ulcer area ranging from 1 to 40 cm².
- The wound stage is in the necrosis stabilization phase, granulation growth phase, or epithelial crawling phase**.
- Voluntary participation in this study and signing the 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;
- The blood sugar level of diabetes is out of control, with fasting blood sugar > 15 mmol/L and glycosylated hemoglobin ≥ 10%;
- There is active bleeding in the wound, and the conventional basic treatment plan cannot be implemented;
- Serum albumin < 20 g/L; hemoglobin < 60 g/L; platelets < 50 × 109/L;
- Disseminated infection or systemic infection state, and antibiotics are being used or will be used for treatment;
- Patients with advanced malignant tumors;
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- The patient is in the active stage of autoimmune diseases;
- The patient has previously been allergic to self-adhesive soft polysilicone silver ion foam dressings (Meipikang Silver) or Anxidean Nano Silver Trauma Patch;
- The patient cannot cooperate or has a mental disorder;
- According to the investigator's judgment, the subject has clear reasons that affect wound healing and is not suitable for this study or cannot comply with the requirements of this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Yunfeng Li, Medical Doctor, +86 010-82267791, liyunfeng1106@163.com
About this study
Official title: Dry Versus Moist Ag Dressings for Local Wound Infections: A Randomized Controlled Trial on Effectiveness and Cost-Effectiveness
This study aims to explore the differences in efficacy and cost-effectiveness between self-adhesive soft polysilicone silver ion foam dressings and traditional silver dressings in local infected wounds through a prospective randomized controlled study. The goal is to provide evidence-based medical support for clinical application, further shorten the wound healing time, and reduce the economic burden on the medical system and patients.
- Conditions
- Chronic Wound, Hard to Heal Wounds, Dressing, Wound he'a'Ling, Wound Healing
- Being tested
- Ag foam dressing named MepilexAg, Dry Ag dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ag foam dressing named MepilexAgDevice
Using MepilexAg in conjunction with conventional clinical treatments in chronic local infectious ulcer
Dry Ag dressingDevice
Using dry Ag dressing in conjunction with conventional clinical treatments
| Study group | Role | What they receive |
|---|---|---|
| MOIST Ag dressing | Experimental | Using MepilexAg in conjunction with conventional clinical treatments Receives: Device: Ag foam dressing named MepilexAg |
| Dry Ag dressing | Active comparator | Using dry Ag dressing in conjunction with conventional clinical treatments Receives: Device: Dry Ag dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound area reduction in two weeks
Pre-treatment area minus post-treatment area, then divided by pre-treatment area
Measured: From enrollment to the end of treatment at 2 weeks
Secondary outcomes (1)
wound healing rate
Percentage of healed wounds to total cases by D14
Measured: From enrollment to the end of treatment at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Sep 2027 (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
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Long Zhang, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07235254
- Sponsor's protocol ID
- Long2025-CW-Ag foam dressing
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dry Versus Moist Ag Dressings for Local Wound Infections: A Randomized Controlled Trial on Effectiveness and Cost-Effectiveness
- ClinicalTrials.gov ID
- NCT07235254
- Acronym / sponsor ID
- Long2025-CW-Ag foam dressing
- Conditions
- Chronic Wound, Hard to Heal Wounds, Dressing, Wound he'a'Ling, Wound Healing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 19 Nov 2025 (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.
This study aims to explore the differences in efficacy and cost-effectiveness between self-adhesive soft polysilicone silver ion foam dressings and traditional silver dressings in local infected wounds through a prospective randomized controlled study. The goal is to provide evidence-based medical support for clinical application, further shorten the wound healing time, and reduce the economic burden on the medical system and patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| MOIST Ag dressing | Experimental | Device: Ag foam dressing named MepilexAgUsing MepilexAg in conjunction with conventional clinical treatments |
| Dry Ag dressing | Active comparator | Device: Dry Ag dressingUsing dry Ag dressing in conjunction with conventional clinical treatments |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient's age ranges from 18 to 80 years old.
- According to the IWII wound infection staging, infected wounds are classified as local infections*.
- The wound type is ulcer, with an ulcer area ranging from 1 to 40 cm².
- The wound stage is in the necrosis stabilization phase, granulation growth phase, or epithelial crawling phase**.
- Voluntary participation in this study and signing the 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;
- The blood sugar level of diabetes is out of control, with fasting blood sugar > 15 mmol/L and glycosylated hemoglobin ≥ 10%;
- There is active bleeding in the wound, and the conventional basic treatment plan cannot be implemented;
- Serum albumin < 20 g/L; hemoglobin < 60 g/L; platelets < 50 × 109/L;
- Disseminated infection or systemic infection state, and antibiotics are being used or will be used for treatment;
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 |
|---|---|---|
| Ag foam dressing named MepilexAgUsing MepilexAg in conjunction with conventional clinical treatments in chronic local infectious ulcer | Device | MOIST Ag dressing |
| Dry Ag dressingUsing dry Ag dressing in conjunction with conventional clinical treatments | Device | Dry Ag dressing |
Primary outcome
wound area reduction in two weeks
Time frame: From enrollment to the end of treatment at 2 weeks
Pre-treatment area minus post-treatment area, then divided by pre-treatment area
1 secondary outcome
wound healing rate
Time frame: From enrollment to the end of treatment at 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ag foam dressing named MepilexAg and Dry Ag dressing in people with Chronic Wound and Hard to Heal Wounds, run by Peking University Third Hospital at 1 site in China.
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 5 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: opening soon, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Long Zhang Executive Deputy Director, Medical Doctor (+86 010-82266699, longzh2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound area reduction in two weeks (time frame: From enrollment to the end of treatment at 2 weeks). 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 19 Nov 2025.