Evaluating a new antibacterial wound dressing for diabetic foot ulcers
A Randomized, Double Blind, Active Controlled, Parallel Group Clinical Trial to Assess the Safety and Efficacy of Nanordica Antibacterial Wound Dressing in Patients With DFUs
This study is testing a new antibacterial wound dressing to see if it helps people with diabetic foot ulcers heal better than a standard dressing.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nanordica Medical OU Industry-sponsored |
| Locations | 11 sites (Tallinn, Harju and 10 other locations) |
| Trial ID | NCT06667752 on ClinicalTrials.gov |
What this trial studies
This clinical trial assesses the safety and efficacy of the Nanordica Advanced Antibacterial Wound Dressing (AAWD) in patients with diabetic foot ulcers. A total of at least 170 participants will be randomly assigned to receive either the AAWD or the Aquacel Ag+ Extra wound dressing for a 4-week treatment period, followed by an 8-week standard care phase. The study aims to determine which dressing provides better healing outcomes for chronic diabetic foot ulcers.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with diabetic foot ulcers present for more than 4 weeks.
Not a fit: Patients with severe infections or those who have undergone recent surgical interventions on the affected leg may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved healing rates for patients with diabetic foot ulcers.
How similar studies have performed: Other studies have shown promising results with advanced wound dressings, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Voluntary, written informed consent obtained prior to any study related activities. * Males and females aged ≥18 years. * DFU(s) present for more than 4 weeks with a maximum diameter of 4 cm. * IWGDF/IDSA Wound infection grades 1 (absent) or 2. * Patients willing and able to comply with scheduled visits, laboratory sampling and study procedures. * Ankle-brachial index (ABI) 0.9-1.4 or ABI between 0.6-0.9 with ankle pressure ≥ 70 mmHg. Exclusion Criteria: * Ssystemic or topical antibiotic therapy within 7 days before the enrolment. * Any wound with known associated osteomyelitis or positive probe-to-bone test. * Previous randomization in this clinical trial. * Surgical procedures in the same leg as the index ulcer(s) (e.g., radical debridement, ulcerectomy, skin grafting, exostectomy, amputation) within the past four weeks, or planned to during the study. * Use of other advanced therapies directly involving the index ulcer(s) (e.g. skin substitutes, matrices, cellbased therapies or products) within the past four weeks. * Patients suffering cardiac disorders grade NYHA IV. * Patients suffering hepatic disorders grade Child-Pugh C. * Stage 4 cancer. * Women of childbearing potential who are pregnant, breast-feeding or not using adequate contraceptive methods.
Where this trial is running
Tallinn, Harju and 10 other locations
- East Tallinn Central Hospital — Tallinn, Harju, Estonia (Recruiting)
- North Estonia Medical Centre Foundation — Tallinn, Harju, Estonia (Recruiting)
- Tartu University Hospital — Tartu, Tartu, Estonia (Recruiting)
- Centro de Salud de Arcos de la Frontera — Arcos de la Frontera, Cádiz, Spain (Recruiting)
- Hospital Puerta del Mar — Cadiz, Cádiz, Spain (Recruiting)
- Centro de Salud San Benito — Jerez de la Frontera, Cádiz, Spain (Recruiting)
- Hospital de León — León, León, Spain (Recruiting)
- Clínica Universitaria de Podología de la Universidad Complutense de Madrid — Madrid, Madrid, Spain (Recruiting)
- Hospital Ramón y Cajal — Madrid, Spain (Recruiting)
- Hospital Universitario Fundación Alcorcón — Madrid, Spain (Recruiting)
- Hospital Universitario de Donostia — San Sebastián, Spain (Recruiting)
Study contacts
- Study coordinator: Grigory Vasiliev
- Email: grigory@nanordica.com
- Phone: +372 5345 2230
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.