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Recruiting NCT06667752

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

No phase Interventional Diabetic Foot Ulcer Diabetic Foot Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Advanced Antibacterial Wound Dressing, Aquacel Ag+ Extra.
Who it may be relevant to
Registry conditions: Diabetic Foot Ulcer, Diabetic Foot Infection. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Estonia, Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • CWC at 12 weeks [Time frame: 12 weeks]
Secondary outcome measures (3)
  • CWC at 4 weeks [Time frame: 4 weeks]
  • Time to heal [Time frame: Up to 12 weeks]
  • Adverse events [Time frame: 12 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Spain · 8 centers
  • Centro de Salud de Arcos de la Frontera — Arcos de la Frontera
  • Hospital Puerta del Mar — Cadiz
  • Centro de Salud San Benito — Jerez de la Frontera
  • Hospital de León — León
  • Clínica Universitaria de Podología de la Universidad Complutense de Madrid — Madrid
  • Hospital Ramón y Cajal — Madrid
  • Hospital Universitario Fundación Alcorcón — Madrid
  • Hospital Universitario de Donostia — San Sebastián
Estonia · 3 centers
  • East Tallinn Central Hospital — Tallinn
  • North Estonia Medical Centre Foundation — Tallinn
  • Tartu University Hospital — Tartu

Identifiers

NCT: NCT06667752 · NM2023 · CIV-ES-24-10-049337

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗