NOrmoBaric Oxygen Therapy Use In Critical Limb ISchemia
Key facts
- Who runs it
- University Hospital, Angers
- Where
- Angers, Cholet, and Le Mans, FranceSee the 3 sites
- Trial code
- Status
- Recruiting
- People taking part
- 200 people, planned
- Started
- 15 Apr 2025
- Expected to end
- Dec 2026
- Type of study
- Observational
- Treatments tested
- introduction of oxygen therapy or not
- Record updated
- 15 June 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 5 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 in France
- University HospitalAngers, FranceContact: Jeanne HERSANT, PhDTaking people
- Hospital CenterCholet, FranceContact: Cedric MD FONTAINENot yet recruiting
- Hospital CenterLe Mans, FranceContact: Claire MD NEVEUXNot yet recruiting
About the trial
What the trial wants to find out
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.
The group in the trial
- hospitalized patients suspected of chronic permanent ischemia realizing transcutaneous oxymetry
hospitalized patients suspected of chronic permanent ischemia realizing transcutaneous oxymetry are enroled in the study. The WIfI score is calculated at the inclusion.
Treatment: introduction of oxygen therapy or not
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 15 June 2026