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

Recruiting now · Not applicable

Conditions studied: Diabetic Foot Ulcer, Diabetic Foot Infection

In brief

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.

Key facts

Study ID

NCT06667752

Run by

Nanordica Medical OU

People needed

170

Starts

2024-10-17

Expected to finish

2026-06-30

Last updated by the study team

2025-08-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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