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 136 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
136
For the first 4 weeks, wound dressing will be changed twice weekly. Subsequently, dressing selection and change frequency will be managed by the investigator as part of the standard of care for another 8 weeks.
For the first 4 weeks, wound dressing will be changed twice weekly. Subsequently, dressing selection and change frequency will be managed by the investigator as part of the standard of care for another 8 weeks.
East Tallinn Central Hospital
Tallinn, Harju, Estonia
North Estonia Medical Centre Foundation
Tallinn, Harju, Estonia
Tartu University Hospital
Tartu, Tartu, Estonia
Composite Wound Healing Response at 12 weeks
Composite Wound Healing Response (CWHR) defined as either a wound area reduction (WAR) of more than 50% at 4 weeks relative to baseline (WAR50/4) and/or complete wound closure (CWC) at 12 weeks (CWC/12)
Time frame: 12 weeks
Wound area reduction at 4 weeks
Wound area reduction at 4 weeks expressed as percent change from baseline measured using the transparent film method
Time frame: 4 weeks
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Centro de Salud de Arcos de la Frontera
Arcos de la Frontera, Cádiz, Spain
Hospital Puerta del Mar
Cadiz, Cádiz, Spain
Centro de Salud San Benito
Jerez de la Frontera, Cádiz, Spain
Hospital de León
León, León, Spain
Clínica Universitaria de Podología de la Universidad Complutense de Madrid
Madrid, Madrid, Spain
Hospital Ramón y Cajal
Madrid, Spain
Hospital Universitario Fundación Alcorcón
Madrid, Spain
...and 1 more locations