Evaluation of Local Capillary Blood Lactate in Chronic Critical Ischemia of Lower Limb Before and After Revascularization

NCT ID: NCT01634815

Last Updated: 2018-02-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-04
• Study Completion Date: 2015-08-21

Brief Summary

Evaluation of a new biological criterion, the local capillary blood lactates to optimize the management of patients with chronic critical ischemia requiring revascularization fast. Potential use in terms of capillary blood lactate as a diagnostic indicator of recurrent ischemia in a limb revascularized.

Conditions

Chronic Critical Ischemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

lactate group

Group Type: EXPERIMENTAL

The Edge

Intervention Type: PROCEDURE

measuring blood lactate

Interventions

The Edge

measuring blood lactate

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Ischemia Chronic critical lower limb revascularization procedure requiring fast.
• Written consent informed patient age greater than or equal to 18

Exclusion Criteria

• Presence of an inflammatory or infectious (erysipelas) in the ischemic member.
• Patients at risk for diabetic foot ie, as defined by the HAS (preventing diabetic foot, 2007)

• presence of sensory neuropathy, and / or
• foot deformities (hallux valgus, hammer toes or claw, prominence of the metatarsal heads), and / or
• history of foot ulceration, and / or
• antecedent of one of these factors (ie antécedant diabetic foot).
• Necrosis of the toes.
• Participation in another clinical research protocol.
• Presence of peripheral arterial disease in the bilateral upper limbs.
• Patient in shock whatever the cause.
• Presence of hepatic failure.
• Too impaired general condition (bedridden, dementia, ...)
• Refusal of the patient to participate in the study
• Protected patients

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre Diemunsch, MD

Role: PRINCIPAL_INVESTIGATOR

not affiliated

Locations

Clinique de l'Orangerie

Strasbourg, , France

Hôpitaux Universitaires de Strasbourg, Service d' Anesthésie Réanimation Chirurgicale

Strasbourg, , France

Countries

France

Other Identifiers

5244

Identifier Type: -

Identifier Source: org_study_id