Clinical trial Recruiting at 1 site Observational Ages 18 and up

Using normobaric oxygen therapy for critical limb ischemia

Official title: NOrmoBaric Oxygen Therapy Use In Critical Limb ISchemia

Run by University Hospital, Angers · NCT06238050 · Data updated 2026-11-12

This study is testing whether normobaric oxygen therapy can help people with severe blood flow problems in their legs feel better compared to regular treatments.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment200 (estimated)
SponsorUniversity Hospital, Angers
Government
Locations3 sites (Angers and 2 other locations)
StatusRecruiting
StartedApril 15, 2025
Main results expectedDecember 2026
Study endsDecember 2026
Registry record updatedJune 15, 2026
Trial IDNCT06238050 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are hospitalized patients diagnosed with chronic permanent ischemia, indicated by resting TcpO2 values below 30mmHg.

Probably not a fit

Patients with acute or decompensated heart or respiratory failure, or those with severe chronic obstructive pulmonary disease (COPD), are unlikely to benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the use of normobaric oxygen therapy in patients with chronic permanent ischemia of the lower limbs, a severe condition characterized by insufficient blood flow. The study will assess the proportion of patients receiving this therapy in routine clinical practice and its potential benefits in improving patient outcomes. By analyzing the Wound, Ischemia, Foot Infection Score (WIfI score), the research will explore improvements in various aspects of the condition, providing insights into the therapy's effectiveness. The hypothesis is that normobaric oxygen therapy may offer medical benefits compared to standard care without oxygen therapy.

Why it matters

Potential benefit: If successful, this study could provide evidence supporting the use of normobaric oxygen therapy as a beneficial treatment for patients with critical limb ischemia.

How similar studies have gone: While there have been studies on hyperbaric oxygen therapy, the specific application of normobaric oxygen therapy in this context is less explored, making this approach relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Patient hospitalized in the recruiting centre.
* Patient fulfilling the clinical and paraclinical criteria (resting TcpO2 values \< 30mmHg) of the definition of chronic permanent ischemia with or without trophic disorders.

Exclusion Criteria:

* Patient suffering from acute or decompensated heart or respiratory failure.
* Patient suffering from chronic obstructive pulmonary disease (COPD) stage III or IV.
* Patient with allergies to medical adhesives

Where it's running

  • University Hospital
    Angers, France
    Recruiting
  • Hospital Center
    Cholet, France
    Not yet recruiting
  • Hospital Center
    Le Mans, France
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.