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Tests treatment safety and results for Wound Heal
Official title An Exploratory Research on the Efficacy and Safety of Antibacterial Absorbable Dressing in Chronic Non-healing Wounds
ClinicalTrials.gov ID: NCT07261501
What this study is testing
- What it's testing
- Antimicrobial absorbable wound dressing is a novel polyester-based degradable dressing. Previous preclinical studies have demonstrated promising efficacy, with a 3-week wound area reduction rate of 63.53% in large animal models, outperforming foreign counterparts (49.47%), without significant adverse reactions observed during application.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Age : 18-80 years
- Wound Type : Chronic non-healing ulcers\ with no signs of healing progression for ≥1 week
- Wound Area : 1-35 cm²
- Infection Status : Local infection, contamination, or colonization\ \ as classified by IWII Wound Infection Staging
- Wound Phase : Late necrotic stabilization phase, granulation phase, or epithelial migration phase\ \ \
You likely can't join if
- Severe Comorbidities : Acute myocardial infarction, heart failure, hepatitis, shock, respiratory failure, or other critical conditions requiring...
- Uncontrolled Diabetes : Fasting blood glucose \>15 mmol/L or HbA1c \>12%
- Active Wound Hemorrhage : Bleeding precluding standard wound therapy
- Critical Laboratory Values : Serum albumin \<20 g/L Hemoglobin \<60 g/L Platelet count \<50×10⁹/L
- Systemic Infection : Disseminated/systemic infection requiring antibiotic therapy
- Malignancy : Advanced cancer patients，Current radiotherapy/chemotherapy，Malignant (cancer-related) ulcers
See the full eligibility criteria
- Age : 18-80 years
- Wound Type : Chronic non-healing ulcers\ with no signs of healing progression for ≥1 week
- Wound Area : 1-35 cm²
- Infection Status : Local infection, contamination, or colonization\ \ as classified by IWII Wound Infection Staging
- Wound Phase : Late necrotic stabilization phase, granulation phase, or epithelial migration phase\ \ \
- Consent : Voluntary participation with signed informed consent
- Severe Comorbidities : Acute myocardial infarction, heart failure, hepatitis, shock, respiratory failure, or other critical conditions requiring stabilization
- Uncontrolled Diabetes : Fasting blood glucose \>15 mmol/L or HbA1c \>12%
- Active Wound Hemorrhage : Bleeding precluding standard wound therapy
- Critical Laboratory Values : Serum albumin \<20 g/L Hemoglobin \<60 g/L Platelet count \<50×10⁹/L
- Systemic Infection : Disseminated/systemic infection requiring antibiotic therapy
- Malignancy : Advanced cancer patients，Current radiotherapy/chemotherapy，Malignant (cancer-related) ulcers
- Untreated Burns : Full-thickness (third-degree) burns without escharotomy
- Active Autoimmune Disease : Flare-up phase of autoimmune disorders
- Pregnancy/Lactation : Pregnant or breastfeeding women
- Allergy : Hypersensitivity to absorbable wound repair materials or polyhexamethylene biguanide hydrochloride
- Non-compliance : Inability to cooperate or psychiatric disorders
- Investigator's Discretion : Any condition deemed to compromise wound healing or study adherence
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 months to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.