Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000902493
Ethics application status
Approved
Date submitted
26/06/2025
Date registered
20/08/2025
Date last updated
20/08/2025
Date data sharing statement initially provided
20/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety and tolerability of plasma-activated water wound rinse for foot ulcers
Scientific title
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
Secondary ID [1] 314755 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
diabetes-related foot ulcer 337971 0
Condition category
Condition code
Infection 334287 334287 0 0
Studies of infection and infectious agents
Metabolic and Endocrine 334695 334695 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 331356 0
Treatment: Other
Intervention code [2] 331642 0
Treatment: Drugs
Comparator / control treatment
Sterile saline
Control group
Placebo

Outcomes
Primary outcome [1] 341947 0
To assess the safety and tolerability of Plasma-Activated Water (PAW) up to 6 weeks after initiation of treatment. Safety and tolerability will be assessed as a composite measure, as both will be based on adverse reactions to PAW.
Timepoint [1] 341947 0
Baseline and weekly for six weeks after initiation of treatment.
Secondary outcome [1] 449127 0
To evaluate the efficacy of Plasma-Activated Water for reducing incidence of infection
Timepoint [1] 449127 0
at 6, 12 and 18 weeks after initiation of treatment
Secondary outcome [2] 450500 0
To evaluate the efficacy of Plasma-Activated Water for improving wound healing rate
Timepoint [2] 450500 0
at 6, 12 and 18 weeks after initiation of treatment
Secondary outcome [3] 450501 0
To evaluate the efficacy of Plasma-Activated Water for improving participant wound-related quality of life
Timepoint [3] 450501 0
baseline, 3, 6, 12, and 18 weeks after initiation of treatment

Eligibility
Key inclusion criteria
1. Adults at least 18 years of age.
2. 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).
3. 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.
4. 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.
5. 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.
6. Able to follow the Investigator's instruction on ulcer care (in the opinion of the Investigator).
7. Agrees to provide written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Planned for revascularisation (open or endovascular) or any major or minor amputation of the index leg within the next 3 months.
2. Active moderate-to-severe infection in the study ulcer, or treatment with intravenous antibiotics within the past two weeks.
3. Any sign (clinical, radiographic) of osteomyelitis associated with the study ulcer.
4. Treatment with systemic immunosuppressants within 90 days of screening.
5. Active malignancy or history of malignancy within five years prior to screening (except for a past history of basal or squamous cell carcinomas).
6. Known history of HIV infection.
7. 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.
8. With any clinical condition or significant concurrent disease judged by the Investigator to complicate the evaluation of the trial treatment.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All clinical personnel and all participants will be blind to the assignment and treatment administered (double-blind). Only one scientific investigator will retain knowledge of treatment based on preparation of treatment and linkage on a spreadsheet with study ID. This spreadsheet will be used to match for study safety and efficacy on end of study, and/or once an SUSAR has been confirmed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The statistical analysis principles described below will be supplemented by a statistical analysis plan (SAP), which will be finalised before the database is locked. Any changes to the statistical plans will be described and justified in the clinical study report (CSR).
The SAP will describe procedures for accounting for missing, unused, and spurious data. This section is a summary of the planned statistical analyses of the primary and secondary endpoints.
All analyses, summaries, and listings will be performed using SAS® software (version 9.4 or higher).
The following descriptive statistics will be used as applicable to summarise the study data, unless otherwise specified:
• Continuous variables: sample size [n], mean, standard deviation [SD], median, minimum [min], and maximum [max].
• Categorical variables: frequencies and percentages.
Individual participant data will be presented in listings.
Efficacy indicators will be summarised descriptively with incidence rates or standard descriptive methods, as appropriate.
Efficacy analysis will be based on data collected up to 12 weeks after initiation of treatment. Assessment of efficacy will be based on the following outcome measures of the study ulcer:
• Days to complete ulcer healing
• Changes in ulcer quality (e.g., infection, signs, pain)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2025
Actual
Date of last participant enrolment
Anticipated
31/08/2026
Actual
Date of last data collection
Anticipated
5/01/2027
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 44355 0
5000 - Adelaide
Recruitment postcode(s) [2] 44356 0
5011 - Woodville South

Funding & Sponsors
Funding source category [1] 319305 0
Government body
Name [1] 319305 0
Department of Health, Disability and Ageing - Medical Research Futures Fund
Country [1] 319305 0
Australia
Primary sponsor type
Government body
Name
Central Adelaide Local Health Network
Address
Country
Australia
Secondary sponsor category [1] 321780 0
University
Name [1] 321780 0
The University of Adelaide
Address [1] 321780 0
Country [1] 321780 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317884 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 317884 0
Ethics committee country [1] 317884 0
Australia
Date submitted for ethics approval [1] 317884 0
16/06/2025
Approval date [1] 317884 0
06/08/2025
Ethics approval number [1] 317884 0
2025/HRE00207

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 142462 0
Prof Robert Fitridge
Address 142462 0
Basil Hetzel Institute, 37A Woodville Road, Woodville South, SA 5011
Country 142462 0
Australia
Phone 142462 0
+61 04 3980 0583
Fax 142462 0
Email 142462 0
[email protected]
Contact person for public queries
Name 142463 0
Neil McMillan
Address 142463 0
Basil Hetzel Institute, 37A Woodville Road, Woodville South, SA 5011
Country 142463 0
Australia
Phone 142463 0
+61 04 0105 1739
Fax 142463 0
Email 142463 0
[email protected]
Contact person for scientific queries
Name 142464 0
Katharina Richter
Address 142464 0
Basil Hetzel Institute, 37A Woodville Road, Woodville South, SA 5011
Country 142464 0
Australia
Phone 142464 0
+61 04 82228447
Fax 142464 0
Email 142464 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
A finite period of: 15 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
Yes: Subject to approval by hospital governance office.



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.