Using normobaric oxygen therapy for critical limb ischemia
NOrmoBaric Oxygen Therapy Use In Critical Limb ISchemia
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 |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Angers Government |
| Locations | 3 sites (Angers and 2 other locations) |
| Trial ID | NCT06238050 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are hospitalized patients diagnosed with chronic permanent ischemia, indicated by resting TcpO2 values below 30mmHg.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Angers and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.