Randomized Double-Blind Trial on Safety and Efficacy of Nanordica Advanced Antibacterial Wound Dressing for Diabetic Foot Ulcer (NM2023)
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 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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Harju
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Tallinn, Harju, Estonia
- East Tallinn Central Hospital
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Tallinn, Harju, Estonia
- North Estonia Medical Centre Foundation
-
-
Tartu
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Tartu, Tartu, Estonia
- Tartu University Hospital
-
-
-
-
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Madrid, Spain
- Hospital Ramón y Cajal
-
Madrid, Spain
- Hospital Universitario Fundación Alcorcón
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San Sebastián, Spain
- Hospital Universitario de Donostia
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Cádiz
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Arcos de la Frontera, Cádiz, Spain
- Centro de Salud de Arcos de la Frontera
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Cadiz, Cádiz, Spain
- Hospital Puerta del Mar
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Jerez de la Frontera, Cádiz, Spain
- Centro de Salud San Benito
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León
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León, León, Spain
- Hospital de León
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Madrid
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Madrid, Madrid, Spain
- Clínica Universitaria de Podología de la Universidad Complutense de Madrid
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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. |
|
Active Comparator: 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Composite Wound Healing Response at 12 weeks
Time Frame: 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) |
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Wound area reduction at 4 weeks
Time Frame: 4 weeks
|
Wound area reduction at 4 weeks expressed as percent change from baseline measured using the transparent film method |
4 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adverse events
Time Frame: 12 weeks
|
Number and severity of adverse events |
12 weeks
|
|
CWC at 12 weeks
Time Frame: 12 weeks
|
Complete wound closure at 12 weeks |
12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NM2023
- CIV-ES-24-10-049337 (Other Identifier: EUDAMED)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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