Critical Ischemia LimbNOBILISNCT06238050
NOrmoBaric Oxygen Therapy Use In Critical Limb ISchemia
An observational study of Critical Ischemia Limb, run by University Hospital, Angers at 3 sites in France.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Ischemia Limb
- What is being tested?
- introduction of oxygen therapy or not
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 3 sitesFrance
- Study dates
- 15 Apr 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: hospitalized patient with symptoms of chronic permanent ischemia
Who may be able to join
- 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 join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
University Hospital
Angers, 49933
Jeanne HERSANT, PhD, (0)241353686 ext. +33, explovasculaire@chu-angers.fr
Jeanne HERSANT, PhD
- Not yet recruiting
Hospital Center
Cholet, 49325
Cedric MD FONTAINE
- Not yet recruiting
Hospital Center
Le Mans, 72000
Claire MD NEVEUX
About this study
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.
Read the 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.
- Conditions
- Critical Ischemia Limb
- Being tested
- introduction of oxygen therapy or not
- Keywords
- oxygen therapy
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
introduction of oxygen therapy or notProcedure or surgery
During hospitalisation, surgeon decides if patient needs and will have an oxygen therapy during this hospitalisation and at home.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: introduction of oxygen therapy or not |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of clinical characteristics of patients, whether or not they benefit from oxygen therapy in usual practices.
Determination of patients' characteristic with or without a prescription of oxygen therapy to inventorized clinical practices.
Measured: 6 months
Comparison of biological characteristics of patients, whether or not they benefit from oxygen therapy in usual practices.
Determination of patients' characteristics with or without a prescription of oxygen therapy to inventorized clinical practices.
Measured: 6 months
Secondary outcomes (7)
Collection of all investigations carried out since inclusion and all modifications of medical therapy or implementation of surgical treatment.
Descriptive study of investigations and therapies (medical and surgical) carried out during the patient's follow-up period
Measured: 6 months
prevalence of decision-making parameters by using the sheet sent to the prescribing doctor by the patient.
Descriptive study of the parameter(s) which allowed the prescriber to make the decision to implement oxygen therapy.
Measured: 6 months
difference in the WIfI score items at inclusion and at 6 months.
Evaluation of the evolution of chronic permanent ischemia according to the administration in current practice of normobaric oxygen therapy.
Measured: 6 months
All-cause mortality at 6 months.
Evaluation of the evolution of chronic permanent ischemia according to the administration in current practice of normobaric oxygen therapy.
Measured: 6 months
occurrence of an amputation between one week after inclusion and 6 months.
Evaluation of the evolution of chronic permanent ischemia according to the administration in current practice of normobaric oxygen therapy.
Measured: 6 months
difference in score obtained at 1 month and at 6 months depending on the presence of chronic permanent ischemia or not and the administration of oxygen or not.
Assessment of the quality of life of patients suspected of chronic permanent ischemia using the Vascu-QOL-6 questionnaire
Measured: 1 and 6 month
Proportion of compliant patients in whom oxygen was prescribed on an outpatient basis
Evaluation of compliance with oxygen for patients benefiting from it
Measured: 1 and 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start15 Apr 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Ischemia LimbStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06238050
- Sponsor's protocol ID
- 49RC22_0236
- Other IDs
- 2023-A02581-44
- Acronym
- NOBILIS
- Status last verified
- Jun 2026
- First submitted
- 28 Nov 2022
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NOrmoBaric Oxygen Therapy Use In Critical Limb ISchemia
- ClinicalTrials.gov ID
- NCT06238050
- Acronym / sponsor ID
- NOBILIS / 49RC22_0236
- Conditions
- Critical Ischemia Limb
- Keywords
- oxygen therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 2 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hospitalized patients suspected of chronic permanent ischemia realizing transcutaneous oxymetry | – | Procedure: introduction of oxygen therapy or nothospitalized patients suspected of chronic permanent ischemia realizing transcutaneous oxymetry are enroled in the study. The WIfI score is calculated at the inclusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hospitalized patient with symptoms of chronic permanent ischemia
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| introduction of oxygen therapy or notDuring hospitalisation, surgeon decides if patient needs and will have an oxygen therapy during this hospitalisation and at home. | Procedure or surgery | hospitalized patients suspected of chronic permanent ischemia realizing transcutaneous oxymetry |
Primary outcome
Comparison of clinical characteristics of patients, whether or not they benefit from oxygen therapy in usual practices.
Time frame: 6 months
Determination of patients' characteristic with or without a prescription of oxygen therapy to inventorized clinical practices.
Comparison of biological characteristics of patients, whether or not they benefit from oxygen therapy in usual practices.
Time frame: 6 months
Determination of patients' characteristics with or without a prescription of oxygen therapy to inventorized clinical practices.
7 secondary outcomes
Collection of all investigations carried out since inclusion and all modifications of medical therapy or implementation of surgical treatment.
Time frame: 6 months
prevalence of decision-making parameters by using the sheet sent to the prescribing doctor by the patient.
Time frame: 6 months
difference in the WIfI score items at inclusion and at 6 months.
Time frame: 6 months
All-cause mortality at 6 months.
Time frame: 6 months
occurrence of an amputation between one week after inclusion and 6 months.
Time frame: 6 months
difference in score obtained at 1 month and at 6 months depending on the presence of chronic permanent ischemia or not and the administration of oxygen or not.
Time frame: 1 and 6 month
Proportion of compliant patients in whom oxygen was prescribed on an outpatient basis
Time frame: 1 and 6 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
Related trials for Critical Ischemia Limb
Recruiting
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
Peripheral Artery Disease, Diabetes Mellitus
RecruitingObservational study
Vessel Recoil in Specific CLTI Populations
Chronic Limb Threatening Ischemia
Not yet recruiting
DCB Outcomes After Non-Compliant Balloon Vessel Preparation With or Without Scoring in Patients With Femoropopliteal Arterial Disease
Femoropopliteal Disease, Drug Coated Balloon
Active, not recruitingObservational study
Laser Atherectomy and Sirolimus-coated Balloon Angioplasty for CLTI
Chronic Limb Threatening Ischemia
RecruitingEarly Phase 1
Nutrition in Patient With Critical Limb Ischemia
Critical Limb Ischemia, Malnutrition
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Ischemia Limb, run by University Hospital, Angers at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeanne MD HERSANT, PhD (241353689 ext. +33(0), jeanne.hersant@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of clinical characteristics of patients, whether or not they benefit from oxygen therapy in usual practices. (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.