Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06238050
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-02
First Post:
2022-11-28
Brief Title:
NOrmoBaric Oxygen Therapy Use In Critical Limb ISchemia
Sponsor:
University Hospital Angers
Organization:
University Hospital Angers
Study Overview
Official Title:
NOrmoBaric Oxygen Therapy Use In Critical Limb ISchemia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NOBILIS
Brief Summary:
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 limbs 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
Detailed Description:
In arterial pathology of the lower limbs at the stage of chronic permanent ischemia very few data exist on the benefit of normobaric oxygen therapy in these patients The purpose of the present study is to report the proportion in usual practice of patients benefiting from normobaric oxygen therapy and to show the interest of the contribution of this therapy in the usual global management of patients presenting with chronic permanent ischemia of the lower limbs
Regarding the Wound Ischemia Foot Infection Score WIfI score it includes three sub-parts each of which has a specific evaluation grid scoring between 0 and 3 From this evaluation grid an overall score can be calculated with different interpretations to determine the risk of amputation at one year as well as the probability of improvement in the event of revascularization ranging from very low risk to high risk Nevertheless the overall evaluation of the score could mask a significant improvement in one of the items evaluated impacting the clinical management and the future of the patient This is why during this study the improvement of each item of the WIfI score separately will be studied
The hypothesis is that putting patients in chronic permanent ischemia on oxygen therapy which is performed frequently brings a medical benefit compared to patients who do not benefit from it
Regarding the Wound Ischemia Foot Infection Score WIfI score it includes three sub-parts each of which has a specific evaluation grid scoring between 0 and 3 From this evaluation grid an overall score can be calculated with different interpretations to determine the risk of amputation at one year as well as the probability of improvement in the event of revascularization ranging from very low risk to high risk Nevertheless the overall evaluation of the score could mask a significant improvement in one of the items evaluated impacting the clinical management and the future of the patient This is why during this study the improvement of each item of the WIfI score separately will be studied
The hypothesis is that putting patients in chronic permanent ischemia on oxygen therapy which is performed frequently brings a medical benefit compared to patients who do not benefit from it
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A02581-44 | OTHER | ANSM | None |