NCT07891208

Brief 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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
31mo left

Started Nov 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 23, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

November 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2028

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

October 23, 2026

Status Verified

October 1, 2026

Enrollment Period

2 years

First QC Date

October 16, 2026

Last Update Submit

October 21, 2026

Conditions

Nasal High Flow Oxygen Therapy Effect on Lower Limb Ischaemia

Outcome Measures

Primary Outcomes (1)

  • 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)

    End of treatment on day 5

Study Arms (1)

Nasal high flow oxygen

EXPERIMENTAL
Device: Nasal high flow oxygen

Interventions

Nasal high flow oxygenDEVICE

Normobaric nasal high flow oxygen for lower limb ischaemia

Nasal high flow oxygen

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Documented CO2 retention.
  • Use of Bleomycin within the last 6-months.
  • Pneumothorax.
  • Craniofacial trauma or surgery.
  • Nasal obstruction.
  • Nasal trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2026

First Posted

October 23, 2026

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

June 1, 2029

Last Updated

October 23, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share