Randomized Double-Blind Trial on Safety and Efficacy of Nanordica Advanced Antibacterial Wound Dressing for Diabetic Foot Ulcer (NM2023)

September 15, 2026 updated by: Nanordica Medical OU

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

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Estonia
    • Harju
      • Tallinn, Harju, Estonia
        • East Tallinn Central Hospital
      • Tallinn, Harju, Estonia
        • North Estonia Medical Centre Foundation
    • Tartu
      • Tartu, Tartu, Estonia
        • Tartu University Hospital
  • Spain
      • Madrid, Spain
        • Hospital Ramon y Cajal
      • Madrid, Spain
        • Hospital Universitario Fundacion Alcorcon
      • San Sebastián, Spain
        • Hospital Universitario de Donostia
    • Cádiz
      • Arcos de la Frontera, Cádiz, Spain
        • Centro de Salud de Arcos de la Frontera
      • Cadiz, Cádiz, Spain
        • Hospital Puerta del Mar
      • Jerez de la Frontera, Cádiz, Spain
        • Centro de Salud San Benito
    • León
      • León, León, Spain
        • Hospital de León
    • Madrid
      • Madrid, Madrid, Spain
        • Clínica Universitaria de Podología de la Universidad Complutense de Madrid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Device: 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
Device: 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

This is where you will find people and organizations involved with this study.

Sponsor

Nanordica Medical OU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

October 30, 2024

First Submitted That Met QC Criteria

October 30, 2024

First Posted (Actual)

October 31, 2024

Study Record Updates

Last Update Posted (Actual)

September 18, 2026

Last Update Submitted That Met QC Criteria

September 15, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

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)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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