A wound dressing with copper and silver nanoparticles versus ionic silver hydrofibre dressing for the treatment of diabetic foot ulcers: a randomised clinical trial.

Roosimaa, M.; Ilumets, H.; Kaha, T.; Kubo, A.-L.; Valkna, A.; Sihtmae, M.; Kadaja, M.; Russell, D.A.; Bondarenko, O.; Vasiliev, G.

A wound dressing with copper and silver nanoparticles versus ionic silver hydrofibre dressing for the treatment of diabetic foot ulcers: a randomised clinical trial.

All Authors

Roosimaa, M.

Ilumets, H.

Kaha, T.

Kubo, A.-L.

Valkna, A.

Sihtmae, M.

Kadaja, M.

Russell, D.A.

Bondarenko, O.

Vasiliev, G.

LTHT Author

Russell, David

LTHT Department

Trauma & Related Services
Leeds Vascular Institute
Vascular Surgery

Publication Date

2026

Item Type

Article

Abstract

Objective: The objective of this trial was to compare the clinical performance and safety of a novel wound dressing containing silver and copper nanoparticles (Nanordica; Nanordica Medical OU, Estonia) (Ag/Cu) with the ionic silver-based dressing Aquacel Ag+ Extra (Convatec Group, UK) (Ag+) for the treatment of infected diabetic foot ulcers (DFUs). Method(s): This study was a single-blinded, randomised, active-controlled pilot trial involving patients with infected DFUs who were randomly assigned to receive either the Ag/Cu or Ag+ dressing. Patients were treated over a one-week active phase with dressing changes every other day, followed by a two-week follow-up phase using a non-antibacterial dressing. Efficacy was measured by wound area size (WAS) reduction, bacterial load control and quality of life (QoL) scores. Safety outcomes were based on adverse events and blood Ag levels. Result(s): The experimental cohort included 30 patients. Consistently better results were observed in nearly all efficacy and safety endpoints for patients treated with the Ag/Cu dressing compared with those treated with the Ag+ dressing. Although WAS decreased in both groups, the WAS in the Ag/Cu dressing group had already decreased by 31% after the first dressing change. By the end of the active phase, the WAS had decreased by 43% in the Ag/Cu dressing group, compared with a 13% reduction in the Ag+ dressing group. The mean total bacterial load in the wound bed did not change significantly in the Ag/Cu dressing group but increased in the Ag+ dressing group. The QoL score increased more in the Ag/Cu dressing group, but this difference did not reach statistical significance. Conclusion(s): The findings of this clinical study indicated that the Ag/Cu dressing is a safe and effective way to treat infected DFUs, demonstrating faster WAS reduction, enhanced bacterial control, and higher QoL scores compared with traditional Ag+ dressings. Declaration of interest: This research was supported by grants from the Development Fund of the National Institute of Chemical Physics and Biophysics, the Estonian Connected Health Cluster, Enterprise Estonia, the European Innovation Council (EIC) Accelerator (Project 190199469 - NANOWOUND), and by the European Union and the Ministry of Education and Research via project TEM-TA55. The funding bodies had no role in the design of the study, data collection, analysis, interpretation, or manuscript preparation. MR, A-LK, AV, MK, OB and GV are employees of Nanordica Medical, Tallinn, Estonia, the company developing the wound dressing studied in this research. The remaining authors have no conflicts of interest.