NCT06667752

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: Nanordica Medical OU · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Foot Ulcer
• Diabetic Foot Infection

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-10-17
• Primary completion: 2025-10-31
• Completion: 2026-06-30
• First posted: 2024-10-31
• Last updated: 2025-08-27

Locations

11 sites across 2 countries: Estonia, Spain