Lower Limb IschaemiaNCT07891208
Nasal High Flow Oxygen in Patients With Lower-Limb Ischaemia
A study testing Nasal high flow oxygen in people with Lower Limb Ischaemia, run by Fisher and Paykel Healthcare.
Trial summary
A prospective, single arm pilot efficacy study designed to evaluate the physiological and symptomatic effects of normobaric Nasal High Flow (NHF) oxygen therapy in patients with lower limb ischaemia experiencing rest pain and/or wound related pain. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Lower Limb Ischaemia
- What is being tested?
- Nasal high flow oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Diagnosed with rest pain and or wound pain due to lower leg ischaemia, with or without an ulcer.
- Aged 16 years and over.
- Able to provide informed consent.
- Able to attend 5 consecutive days for the study.
Who cannot join
- Documented CO2 retention.
- Use of Bleomycin within the last 6-months.
- Pneumothorax.
- Craniofacial trauma or surgery.
- Nasal obstruction.
- Nasal trauma
About this study
Official title: A Prospective Pilot Efficacy Study of Nasal High Flow Oxygen in Patients With Lower-Limb Ischaemia
A prospective, single arm pilot efficacy study designed to evaluate the physiological and symptomatic effects of normobaric Nasal High Flow (NHF) oxygen therapy in patients with lower limb ischaemia experiencing rest pain and/or wound related pain.
- Conditions
- Lower Limb Ischaemia
- Being tested
- Nasal high flow oxygen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal high flow oxygenDevice
Normobaric nasal high flow oxygen for lower limb ischaemia
| Study group | Role | What they receive |
|---|---|---|
| Nasal high flow oxygen | Experimental | Not described Receives: Device: Nasal high flow oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on rest and/or wound pain score
Does elevated FiO2 affect rest or wound pain score assessed with 11 point verbal numerical rating scale (vNRS-11). Score range between 0 (no pain) and 10 (maximum pain).
Measured: End of treatment on day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb IschaemiaStudies of the same condition, open and under way.
- More trials run by Fisher and Paykel HealthcareThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891208
- Sponsor's protocol ID
- CIA-380
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Pilot Efficacy Study of Nasal High Flow Oxygen in Patients With Lower-Limb Ischaemia
- ClinicalTrials.gov ID
- NCT07891208
- Acronym / sponsor ID
- CIA-380
- Conditions
- Lower Limb Ischaemia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 23 Oct 2026 (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.
A prospective, single arm pilot efficacy study designed to evaluate the physiological and symptomatic effects of normobaric Nasal High Flow (NHF) oxygen therapy in patients with lower limb ischaemia experiencing rest pain and/or wound related pain.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nasal high flow oxygen | Experimental | Device: Nasal high flow oxygen |
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)
- Diagnosed with rest pain and or wound pain due to lower leg ischaemia, with or without an ulcer.
- Aged 16 years and over.
- Able to provide informed consent.
- Able to attend 5 consecutive days for the study.
Key exclusion criteria (6 listed)
- Documented CO2 retention.
- Use of Bleomycin within the last 6-months.
- Pneumothorax.
- Craniofacial trauma or surgery.
- Nasal obstruction.
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 |
|---|---|---|
| Nasal high flow oxygenNormobaric nasal high flow oxygen for lower limb ischaemia | Device | Nasal high flow oxygen |
Primary outcome
Effect on rest and/or wound pain score
Time frame: End of treatment on day 5
Does elevated FiO2 affect rest or wound pain score assessed with 11 point verbal numerical rating scale (vNRS-11). Score range between 0 (no pain) and 10 (maximum pain).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal high flow oxygen in people with Lower Limb Ischaemia, run by Fisher and Paykel Healthcare.
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 6 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: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect on rest and/or wound pain score (time frame: End of treatment on day 5). 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 26 Oct 2026.