RecruitingNot ApplicableNCT06667752

Randomized Double-Blind Trial on Safety and Efficacy of Nanordica Advanced Antibacterial Wound Dressing for Diabetic Foot Ulcer

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


Sponsor

Nanordica Medical OU

Enrollment

170 participants

Start Date

Oct 17, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Advanced Antibacterial Wound Dressing and a medical device called Aquacel Ag+ Extra for people with diabetic foot infection and diabetic foot ulcer. The study is currently recruiting participants at 11 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAdvanced Antibacterial Wound Dressing

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.

DEVICEAquacel Ag+ Extra

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.


Locations(11)

East Tallinn Central Hospital

Tallinn, Harju, Estonia

North Estonia Medical Centre Foundation

Tallinn, Harju, Estonia

Tartu University Hospital

Tartu, Tartu, Estonia

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

Hospital Universitario de Donostia

San Sebastián, Spain

View Full Details on ClinicalTrials.gov

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NCT06667752


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