Chronic Leg UlcerNCT05422248
Oxygen Wound Therapy Feasibility Study
A study testing Series Topical Oxygen Therapy and Paired Topical Oxygen Therapy in people with Chronic Leg Ulcer, run by Fisher and Paykel Healthcare at 1 site in New Zealand.
Trial summary
Determine the feasibility of using a new topical oxygen therapy device to treat hard to heal lower leg wounds. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Chronic Leg Ulcer
- What is being tested?
- Series Topical Oxygen Therapy and Paired Topical Oxygen Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNew Zealand
- Study dates
- 1 Dec 2022to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
New Zealand1 site, 1 recruiting
- Recruiting
Otago Vascular Diagnostics
Dunedin, Otago, 9016
Clinical Director, +64 3 474 0999
Clinical Nurse Specialist, +64 3 474 0999
About this study
Determine the feasibility of using a new topical oxygen therapy device to treat hard to heal lower leg wounds.
- Conditions
- Chronic Leg Ulcer
- Being tested
- Series Topical Oxygen Therapy, Paired Topical Oxygen Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Series Topical Oxygen TherapyDevice
Standard care provided to the whole wound followed by intervention device care to the whole wound.
Paired Topical Oxygen TherapyDevice
Care provided to one portion of wound by intervention device and standard care to remaining portion of wound.
| Study group | Role | What they receive |
|---|---|---|
| Series | Active comparator | Standard wound care for 4 weeks followed by intervention device wound care for up to 12 weeks. Receives: Device: Series Topical Oxygen Therapy |
| Paired | Active comparator | 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. Receives: Device: Paired Topical Oxygen Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in wound area
cm^2
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start1 Dec 2022
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Leg UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jolanta Krysa, Principal investigator, Southern DHB Vascular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05422248
- Sponsor's protocol ID
- CIA-297
- Status last verified
- Sep 2023
- First submitted
- 13 Jun 2022
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygen Wound Therapy Feasibility Study
- ClinicalTrials.gov ID
- NCT05422248
- Acronym / sponsor ID
- CIA-297
- Conditions
- Chronic Leg Ulcer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 16 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine the feasibility of using a new topical oxygen therapy device to treat hard to heal lower leg wounds.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Series | Active comparator | Device: Series Topical Oxygen TherapyStandard wound care for 4 weeks followed by intervention device wound care for up to 12 weeks. |
| Paired | Active comparator | Device: Paired Topical Oxygen TherapyIntervention device wound care to a portion of wound and standard wound care to the remaining portion of the wound, for up to 12 weeks. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Series Topical Oxygen TherapyStandard care provided to the whole wound followed by intervention device care to the whole wound. | Device | Series |
| Paired Topical Oxygen TherapyCare provided to one portion of wound by intervention device and standard care to remaining portion of wound. | Device | Paired |
Primary outcome
Change in wound area
Time frame: 12 weeks
cm^2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jolanta Krysa principal investigator
Southern DHB Vascular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Series Topical Oxygen Therapy and Paired Topical Oxygen Therapy in people with Chronic Leg Ulcer, run by Fisher and Paykel Healthcare at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Geoff Bold (+64 (09) 574 0100, geoff.bold@fphcare.co.nz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in wound area (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.