Obliterating Arteriopathy of the Lower Limbs | Protection of Arteritic Patients by Remote Preconditioning
Obliterating Arteriopathy of the Lower Limbs research study
What is the primary objective of this study?
Prospective, monocentric, randomised, double-blind study with 20 patients enrolled to be explored twice through a Cross-over strategy to determine whether remote preconditioning improves arteritic patients' ability to walk.
Who is eligible to participate?
Inclusion Criteria: - Positive treadmill test (maximum walking distance < 750m because of lower limbs muscular pain) - Resting systolic pressure index < 0,9 (uni- or bilateral) - Resting systolic blood pressure <200mmHg - Written informed consent - Affiliation to a Social Security scheme Exclusion Criteria: - Effort hypoxemia during the selection treadmill test - Patient treated with metformin during the 7 days preceding the treadmill tests - Person who is not affiliated to a Social Security scheme or benefiting from such a scheme - Person in an exclusion period related to another biomedical study - Patient refusal / patient not having provided written informed consent
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Obliterating Arteriopathy of the Lower Limbs
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Procedure:Remote ischemic preconditioningA blood pressure cuff is placed on one arm and is inflated to 200mmHg during 5 minutes. During the following 5 minutes, the cuff is inflated at the same pressure on the contralateral arm. This sequence is repeated 3 times, that is to say 3 sequences of cuff inflation for 5 minutes on each arm followed by 5 minutes without inflation. The treadmill test starts 5 minutes after the end of the last deflation of the cuff.
Procedure:ControlA blood pressure cuff is placed on one arm and is inflated to 10mmHg during 5 minutes. During the following 5 minutes, the cuff is inflated at the same pressure on the contralateral arm. This sequence is repeated 3 times, that is to say 3 sequences of cuff inflation for 5 minutes on each arm followed by 5 minutes without inflation. The treadmill test starts 5 minutes after the end of the last deflation of the cuff.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: October 2013
Completed Date: December 2013
Primary Outcome: Walking distance during the calibrated treadmill test
Secondary Outcome: Tissue oxygenation measure by Near Infra-Red Spectroscopy during the test
Study sponsors, principal investigator, and references
Principal Investigator: Fabrice PRUNIER, Professor
Lead Sponsor: University Hospital, Angers