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 type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | University Hospital, Angers Government |
| Locations | 3 sites (Angers and 2 other locations) |
| Status | Recruiting |
| Started | April 15, 2025 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | June 15, 2026 |
| Trial ID | NCT06238050 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
- Study coordinator: Jeanne MD HERSANT, PhD
- Email: jeanne.hersant@chu-angers.fr
- Phone: 241353689
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.