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Taking people in FranceNo phase

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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
15 June 2026