Actively Recruiting

Age: 18Years +
All Genders
NCT06238050

NOrmoBaric Oxygen Therapy Use In Critical Limb ISchemia

Led by University Hospital, Angers · Updated on 2025-04-25

200

Participants Needed

3

Research Sites

85 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

NOrmoBaric Oxygen Therapy Use In Critical Limb ISchemia

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient hospitalized in the recruiting centre.
  • Patient meeting clinical and paraclinical criteria of chronic permanent ischemia with resting transcutaneous oxygen (TcpO2) values less than 30 mmHg, with or without trophic disorders.
Not Eligible

You will not qualify if you...

  • Patient with acute or decompensated heart or respiratory failure.
  • Patient with chronic obstructive pulmonary disease (COPD) stage III or IV.
  • Patient allergic to medical adhesives.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

University Hospital

Angers, France, 49933

Actively Recruiting

2

Hospital Center

Cholet, France, 49325

Not Yet Recruiting

3

Hospital Center

Le Mans, France, 72000

Not Yet Recruiting

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Research Team

J

Jeanne MD HERSANT, PhD

CONTACT

M

Marine MAUBOUSSIN

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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NOrmoBaric Oxygen Therapy Use In Critical Limb ISchemia | DecenTrialz