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

Not Applicable

Recruiting

• Conditions: Diabetic Foot Ulcer; Diabetic Foot Infection

• Registration Number: NCT06667752
• Lead Sponsor: Nanordica Medical OU

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-17
• Study First Submitted: 2024-10-30
• Study First Submitted QC: 2024-10-30
• Study First Posted: 2024-10-31
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-26
• Last Update Posted: 2025-08-27
• Primary Completion: 2025-10-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 170

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
CWC at 12 weeks	12 weeks	complete wound closure (CWC) at 12 weeks

Secondary Outcome Measures

Name	Time	Method
CWC at 4 weeks	4 weeks	complete wound closure (CWC) at 4 weeks
Time to heal	Up to 12 weeks	Time until complete wound closure.
Adverse events	12 weeks	Number and severity of adverse events

Trial Locations

Locations (11)

East Tallinn Central Hospital; 🇪🇪 Tallinn, Harju, Estonia

North Estonia Medical Centre Foundation; 🇪🇪 Tallinn, Harju, Estonia

Tartu University Hospital; 🇪🇪 Tartu, Tartu, Estonia

Hospital Ramón y Cajal; 🇪🇸 Madrid, Spain

Hospital Universitario Fundación Alcorcón; 🇪🇸 Madrid, Spain

Hospital Universitario de Donostia; 🇪🇸 San Sebastián, Spain

Centro de Salud de Arcos de la Frontera; 🇪🇸 Arcos de la Frontera, Cádiz, Spain

Hospital Puerta del Mar; 🇪🇸 Cadiz, Cádiz, Spain

Centro de Salud San Benito; 🇪🇸 Jerez de la Frontera, Cádiz, Spain

Hospital de León; 🇪🇸 León, León, Spain

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