Antibacterial absorbable polyester dressing for chronic non-healing wounds
Official title: An Exploratory Research on the Efficacy and Safety of Antibacterial Absorbable Dressing in Chronic Non-healing Wounds
Run by Peking University Third Hospital · NCT07261501 · Data updated 2026-11-12
This trial will test an antimicrobial absorbable polyester dressing to see if it helps adults with chronic non-healing ulcers heal faster and safely.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Months to 80 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Peking University Third Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | November 1, 2025 |
| Main results expected | February 1, 2026 |
| Study ends | November 1, 2026 |
| Registry record updated | December 3, 2025 |
| Trial ID | NCT07261501 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–80 with chronic non-healing ulcers (1–35 cm²) that show no healing progression for ≥1 week, including wounds with local infection/colonization and in late necrotic, granulation, or epithelial migration phases, who can give informed consent.
✕Probably not a fit
Patients with severe unstable comorbidities, uncontrolled diabetes (fasting glucose >15 mmol/L or HbA1c >12%), active bleeding that prevents standard care, systemic/disseminated infection, critically low albumin/hemoglobin/platelets, or advanced cancer are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center interventional study will apply a novel antimicrobial absorbable polyester dressing to adults with chronic non-healing wounds and follow them using modern clinical wound-evaluation methods and established chronic wound staging. Prior large- and small-animal studies showed faster wound-area reduction and no major toxicity, but human clinical evidence is lacking. Participants will meet defined size, phase, and infection-stage criteria and will be monitored for wound-area change and safety outcomes. The goal is to identify optimal indications and generate clinical evidence on efficacy and tolerability at Peking University Third Hospital.
Why it matters
Potential benefit: If successful, the dressing could speed wound closure and reduce infection risk for people with chronic non-healing ulcers.
How similar studies have gone: Preclinical large- and small-animal studies reported promising wound-area reduction and acceptable toxicity, but clinical human data for this specific absorbable antimicrobial dressing are currently lacking.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * 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
Where it's running
-
Peking University Third Hospital
Beijing, Beijing Municipality, China Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.