NOrmoBaric Oxygen Therapy Use In Critical Limb ISchemia
Recruiting now
Conditions studied: Critical Ischemia Limb
In brief
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.
Key facts
- Study ID
- NCT06238050
- Run by
- University Hospital, Angers
- People needed
- 200
- Starts
- 2025-04-15
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-06-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- University Hospital — Angers, France (enrolling)
- Hospital Center — Cholet, France
- Hospital Center — Le Mans, France
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.