{
  "abstract": "Introduction Patients living with diabetes-related foot ulcers (DFU) often have non-healing wounds that, despite ongoing clinical management and wound debridement as standard of care, can proceed to infection and lower limb amputation. Additionally, treatment guidelines do not recommend most topical antibiotics or antiseptic treatments, limiting complements to surgical wound debridement. We present a protocol for a phase I randomised controlled trial testing the safety and efficacy of plasma-activated water as an antiseptic for preventing infection and promoting ulcer healing.Methods and analysis This protocol describes a single-centre, two-armed (1:1 allocation), double-blinded, randomised controlled trial of plasma-activated water (PAW) for the treatment of non-healing DFU. 20 participants will be randomised to the control (standard care with 10-minute treatment with saline-soaked gauze twice weekly for 6 weeks) or intervention group (same but with 10-minute treatment with PAW-soaked gauze instead). Primary outcome is the safety and tolerability of PAW in treating non-healing wounds, while secondary outcome is the effect on promoting wound healing and antimicrobial activity.Ethics and dissemination The Central Adelaide Local Health Network Human Research Ethics Committee (2025/HRE00207) has approved the study. Results will be presented at international conferences and published in a peer-reviewed clinical journal.Trial registration number This trial was registered in the Australia New Zealand Clinical Trials Registry (registration number ACTRN12625000902493) on 20 August 2025.",
  "authors": [
    {
      "affiliations": [
        "School of Pharmacy and Biomedical Science, College of Health, Adelaide University, Adelaide, South Australia, Australia",
        "Basil Hetzel Institute for Translational Health Research, The Queen Elizabeth Hospital, Adelaide University, Adelaide, South Australia, Australia",
        "Study Group for Biofilms (ESGB), European Society of Clinical Microbiology and Infectious Diseases, Basel, Switzerland"
      ],
      "name": "Adrian I Abdo"
    },
    {
      "affiliations": [
        "Basil Hetzel Institute for Translational Health Research, The Queen Elizabeth Hospital, Adelaide University, Adelaide, South Australia, Australia",
        "School of Medicine, College of Health, Adelaide University, Adelaide, South Australia, Australia",
        "Department of Vascular and Endovascular Surgery, Royal Adelaide Hospital, Adelaide, South Australia, Australia"
      ],
      "name": "Neil Mcmillan"
    },
    {
      "affiliations": [
        "Basil Hetzel Institute for Translational Health Research, The Queen Elizabeth Hospital, Adelaide University, Adelaide, South Australia, Australia",
        "Department of Vascular and Endovascular Surgery, Royal Adelaide Hospital, Adelaide, South Australia, Australia"
      ],
      "name": "Li Lao"
    },
    {
      "affiliations": [
        "Basil Hetzel Institute for Translational Health Research, The Queen Elizabeth Hospital, Adelaide University, Adelaide, South Australia, Australia",
        "School of Medicine, College of Health, Adelaide University, Adelaide, South Australia, Australia",
        "Department of Vascular and Endovascular surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia"
      ],
      "name": "Guilherme N Pena"
    },
    {
      "affiliations": [
        "Basil Hetzel Institute for Translational Health Research, The Queen Elizabeth Hospital, Adelaide University, Adelaide, South Australia, Australia",
        "School of Medicine, College of Health, Adelaide University, Adelaide, South Australia, Australia",
        "Department of Vascular and Endovascular Surgery, Royal Adelaide Hospital, Adelaide, South Australia, Australia"
      ],
      "name": "Robert Fitridge"
    },
    {
      "affiliations": [
        "School of Pharmacy and Biomedical Science, College of Health, Adelaide University, Adelaide, South Australia, Australia",
        "Basil Hetzel Institute for Translational Health Research, The Queen Elizabeth Hospital, Adelaide University, Adelaide, South Australia, Australia",
        "Study Group for Biofilms (ESGB), European Society of Clinical Microbiology and Infectious Diseases, Basel, Switzerland",
        "Institute for Photonics and Advanced Sensing, Adelaide University, Adelaide, South Australia, Australia"
      ],
      "name": "Katharina Richter"
    }
  ],
  "title": "Plasma-activated water as a wound rinse solution in patients with diabetes-related foot ulcers in two Australian hospitals: study protocol for a phase I double-blinded, randomised controlled trial",
  "uid": "189bb872-ef26-5c7a-9d3d-6c340ef068bb"
}