Safety and tolerability of plasma-activated water wound rinse for foot ulcers
A Phase I randomised clinical trial assessing safety and tolerability of Plasma-Activated Water as a novel wound rinse agent in patients with diabetes-related foot ulcers
Central Adelaide Local Health Network
20 participants
Sep 1, 2025
Interventional
Conditions
Summary
For this study, participants will have full wound standard-of-care provided by an experienced clinical trial wound nurse, with a wound rinse performed with one of two agents: saline control, or plasma-activated water (PAW). This novel solution has the potential to be a rapid-acting wound cleaning agent that will kill bacteria in biofilm without engendering antibiotic-resistant organisms. As a first-in-human study of a product with a favourable safety profile, we expect this trial to place CALHN researchers and patients at the forefront of new infection control technologies.
Eligibility
Inclusion Criteria13
- Adults at least 18 years of age.
- Have a current diagnosis of diabetes mellitus (DM) characterized by at least one of the following:
- currently under DM medication treatment
- with HbA1c greater than or equal to 6.5%
- with fasting plasma glucose greater than or equal to 7.0 mmol/L
- with plasma glucose greater than or equal to 11.1 mmol/L in the two-hour 75-gram oral glucose tolerance test (OGTT).
- With at least one cutaneous ulcer on the foot, which meets all the following criteria:
- area between 2 and 20 cm2 at the time of enrolment.
- has been under the standard care of the Investigator for at least 4 weeks.
- With ankle brachial index (ABI) greater than or equal to 0.4 and/or toe pressure greater than or equal to 30 mmHg on the limb with the study ulcer.
- The participant has a life expectancy of at least 6 months as determined by the Investigator based on a combination of medical history, physical examination, vital signs, clinical laboratory tests, and other risk stratification assessments.
- Able to follow the Investigator's instruction on ulcer care (in the opinion of the Investigator).
- Agrees to provide written informed consent.
Exclusion Criteria8
- Planned for revascularisation (open or endovascular) or any major or minor amputation of the index leg within the next 3 months.
- Active moderate-to-severe infection in the study ulcer, or treatment with intravenous antibiotics within the past two weeks.
- Any sign (clinical, radiographic) of osteomyelitis associated with the study ulcer.
- Treatment with systemic immunosuppressants within 90 days of screening.
- Active malignancy or history of malignancy within five years prior to screening (except for a past history of basal or squamous cell carcinomas).
- Known history of HIV infection.
- Received any investigational research agent within 60 days or within five half-lives of the last treatment (if the half-life of the investigational agent is known to be longer than 12 days) prior to the planned initiation of study treatment.
- With any clinical condition or significant concurrent disease judged by the Investigator to complicate the evaluation of the trial treatment.
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Interventions
Participants will receive 20mL plasma-activated water as a rinse, applied to gauze as a temporary dressing, for ten minutes during a clinic appointment. Rinse will be applied by study clinical investigator (registered nurse, podiatrist, or medical scientist) once per week for six weeks. Adherence to study procedures and standard of care (e.g., wearing of clinical offloading) will be assessed from medical records and review at appointments.
Locations(1)
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ACTRN12625000902493