NCT06238050 NOrmoBaric Oxygen Therapy Use In Critical Limb ISchemia
| NCT ID | NCT06238050 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Angers |
| Condition | Critical Ischemia Limb |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-04-15 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2025-04-15 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Peripheral arteriopathy disease (PAD) affects 1 million people in France. In its most advanced stage: chronic permanent ischemia also called critical ischemia, the prognosis of patients is burdened with a one-year mortality rate of 30%. Chronic permanent ischemia results from a lack of oxygen supply to the microcirculatory network, responsible for tissue death and the development of trophic disorders. In this context, many studies have focused on the contribution of hyperbaric oxygen therapy, however none demonstrates with certainty its beneficial effect with a heavy set-up for teams and patients. Furthermore, it appears that normobaric oxygen therapy could have its place in this context by temporarily restoring a sufficient level of transcutaneous oxygen. However, even if normobaric oxygen therapy is common practice although empirical for some practitioners, no data demonstrates its real interest. The purpose of this study is therefore to report the proportion, in usual practice, of patients with permanent chronic ischemia of the lower limb(s), benefiting from normobaric oxygen therapy, but also to show the interest of the contribution of this therapy in usual comprehensive management of these patients. This is a pilot study, after which, if the hypothesis is confirmed, it may be proposed to carry out a randomized study, on a large scale, in order to validate the use of normobaric oxygen therapy in the context of chronic permanent ischemia.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06238050 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Critical Ischemia Limb. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06238050 currently recruiting?
Yes, NCT06238050 is actively recruiting participants. Contact the research team at jeanne.hersant@chu-angers.fr for enrollment information.
Where is the NCT06238050 trial being conducted?
This trial is being conducted at Angers, France, Cholet, France, Le Mans, France.
Who is sponsoring the NCT06238050 clinical trial?
NCT06238050 is sponsored by University Hospital, Angers. The trial plans to enroll 200 participants.