Randomized Double-Blind Trial on Safety and Efficacy of Nanordica Advanced Antibacterial Wound Dressing for Diabetic Foot Ulcer
NCT ID: NCT06667752
Last Updated: 2025-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
170 participants
INTERVENTIONAL
2024-10-17
2026-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Advanced Antibacterial Wound Dressing
Advanced 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.
Aquacel Ag+ Extra
Aquacel 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.
Interventions
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Advanced 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.
Aquacel 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Nanordica Medical OU
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CIV-ES-24-10-049337
Identifier Type: OTHER
Identifier Source: secondary_id
NM2023
Identifier Type: -
Identifier Source: org_study_id
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