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

• Status Verified: 2024-10
• Study Start: 2024-10-17
• Study First Submitted: 2024-10-30
• Study First Submitted QC: 2024-10-30
• Last Update Submitted: 2024-10-30
• Study First Posted: 2024-10-31
• Last Update Posted: 2024-10-31
• 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.
• Patients suffering DFUs for more than 4 weeks with a maximum diameter of 4 cm.
• Wound infection grades 1 (absent) or 2.
• Patients willing and able to comply with scheduled visits, laboratory sampling and study procedures.

Exclusion Criteria

• Patients receiving systemic or topical antibiotic therapy within 7 days before the enrolment.
• Patients with any wound with known associated osteomyelitis or positive probe-to-bone test.
• Patients who have previously been randomized in this clinical trial.
• Patients who have undergone surgical procedures (e.g., radical debridement, ulcerectomy, surgical offloading, revascularization) or other advanced therapies (e.g. skin substitutes, negative pressure therapy, hyperbaric oxygen therapy) in the same leg than the index wound(s) (i.e., the ones treated and evaluated during the study) within the past four weeks, or are planned to undertake such procedures.
• Patients suffering cardiac disorders grade NYHA IV.
• Patients suffering hepatic disorders grade Child-Pugh C.
• Patients suffering advanced (stage 4) cancer.
• Patients with ankle-brachial pressure index ≤0.8 or limb peripheral arterial pressure <60 mmHg.
• 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
Time to heal	Up to 12 weeks	Time until complete wound closure.
Adverse events	12 weeks	Number and severity of adverse events
CWC at 4 weeks	4 weeks	complete wound closure (CWC) at 4 weeks

Trial Locations

Locations (5)

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

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

Hospital Puerta del Mar; 🇪🇸 Cádiz, Spain

Hospital de León; 🇪🇸 León, Spain

Clínica Universitaria de Podología de la Universidad Complutense de Madrid; 🇪🇸 Madrid, Spain