Actively Recruiting
Randomized Double-Blind Trial on Safety and Efficacy of Nanordica Advanced Antibacterial Wound Dressing for Diabetic Foot Ulcer
Led by Nanordica Medical OU · Updated on 2025-08-27
170
Participants Needed
11
Research Sites
88 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial evaluates the safety and efficacy of the Nanordica Advanced Antibacterial Wound Dressing (AAWD) in patients suffering from diabetic foot ulcers. At least 170 participants will be randomly allocated to be treated either with AAWD or Aquacel Ag+ Extra wound dressing for a 4-week active phase (intervention) followed by an 8-week standard of care period.
CONDITIONS
Official Title
Randomized Double-Blind Trial on Safety and Efficacy of Nanordica Advanced Antibacterial Wound Dressing for Diabetic Foot Ulcer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided voluntary, written informed consent before any study activities
- Male or female aged 18 years or older
- Diabetic foot ulcer(s) present for more than 4 weeks with a maximum size of 4 cm diameter
- Wound infection graded 1 (absent) or 2 according to IWGDF/IDSA
- Willing and able to attend scheduled visits, laboratory tests, and study procedures
- Ankle-brachial index (ABI) between 0.9 and 1.4, or ABI between 0.6 and 0.9 with ankle pressure at least 70 mmHg
You will not qualify if you...
- Received systemic or topical antibiotic therapy within 7 days before enrollment
- Any wound with known osteomyelitis or positive probe-to-bone test
- Previously randomized in this clinical trial
- Surgical procedures on the same leg as the index ulcer(s) within past 4 weeks or planned during the study
- Use of other advanced therapies involving the index ulcer(s) within past 4 weeks
- Cardiac disorders classified as NYHA grade IV
- Hepatic disorders classified as Child-Pugh grade C
- Stage 4 cancer
- Women of childbearing potential who are pregnant, breastfeeding, or not using adequate contraception
AI-Screening
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Trial Site Locations
Total: 11 locations
1
East Tallinn Central Hospital
Tallinn, Harju, Estonia
Actively Recruiting
2
North Estonia Medical Centre Foundation
Tallinn, Harju, Estonia
Actively Recruiting
3
Tartu University Hospital
Tartu, Tartu, Estonia
Actively Recruiting
4
Centro de Salud de Arcos de la Frontera
Arcos de la Frontera, Cádiz, Spain
Actively Recruiting
5
Hospital Puerta del Mar
Cadiz, Cádiz, Spain
Actively Recruiting
6
Centro de Salud San Benito
Jerez de la Frontera, Cádiz, Spain
Actively Recruiting
7
Hospital de León
León, León, Spain
Actively Recruiting
8
Clínica Universitaria de Podología de la Universidad Complutense de Madrid
Madrid, Madrid, Spain
Actively Recruiting
9
Hospital Ramón y Cajal
Madrid, Spain
Actively Recruiting
10
Hospital Universitario Fundación Alcorcón
Madrid, Spain
Actively Recruiting
11
Hospital Universitario de Donostia
San Sebastián, Spain
Actively Recruiting
Research Team
G
Grigory Vasiliev
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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