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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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.
• Устройство 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.

Первичные конечные точки

• CWC at 12 weeks [Срок оценки: 12 weeks]

Вторичные конечные точки (3)

• CWC at 4 weeks [Срок оценки: 4 weeks]
• Time to heal [Срок оценки: Up to 12 weeks]
• Adverse events [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Испания · 8 центров

• 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

Эстония · 3 центра

• East Tallinn Central Hospital — Tallinn
• North Estonia Medical Centre Foundation — Tallinn
• Tartu University Hospital — Tartu

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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