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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

bmjopen · 2026-07-10 · canonical JSON source

11 visible annotations · policy: published · automated confidence ≥ 75.00%

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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.