Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05422248




Registration number
NCT05422248
Ethics application status
Date submitted
13/06/2022
Date registered
16/06/2022
Date last updated
13/09/2023

Titles & IDs
Public title
Oxygen Wound Therapy Feasibility Study
Scientific title
Oxygen Wound Therapy Feasibility Study
Secondary ID [1] 0 0
CIA-297
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Leg Ulcer 0 0
Condition category
Condition code
Skin 0 0 0 0
Other skin conditions
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Series Topical Oxygen Therapy
Treatment: Devices - Paired Topical Oxygen Therapy

Active Comparator: Series - Standard wound care for 4 weeks followed by intervention device wound care for up to 12 weeks.

Active Comparator: Paired - Intervention device wound care to a portion of wound and standard wound care to the remaining portion of the wound, for up to 12 weeks.


Treatment: Devices: Series Topical Oxygen Therapy
Standard care provided to the whole wound followed by intervention device care to the whole wound.

Treatment: Devices: Paired Topical Oxygen Therapy
Care provided to one portion of wound by intervention device and standard care to remaining portion of wound.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in wound area
Timepoint [1] 0 0
12 weeks

Eligibility
Key inclusion criteria
- Patients with hard to heal lower leg wounds as determined by the treating clinician.

- Patient has a wound area greater than the area of the interface

- Aged 16 years and over

- Able to provide informed consent
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Lower limb wounds with bone or tendon exposed

- Infected wounds which require treatment with antibiotics

- Wounds with critical bioburden requiring a medicated dressing

- Wounds that require dressing changes more than every second day, for example high
exudating wounds

- Wounds with slough covering more than 30% of the wound surface

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2026
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Otago

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Fisher and Paykel Healthcare
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Determine the feasibility of using a new topical oxygen therapy device to treat hard to heal
lower leg wounds.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05422248
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jolanta Krysa
Address 0 0
Southern DHB Vascular Surgery
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Geoff Bold
Address 0 0
Country 0 0
Phone 0 0
+64 (09) 574 0100
Fax 0 0
Email 0 0
geoff.bold@fphcare.co.nz
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05422248