Actively Recruiting
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
Eligibility Criteria
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.
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
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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
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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