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

Not Applicable

Terminated

• Conditions: Chronic Critical Ischemia
• Interventions: Procedure: The Edge

• Registration Number: NCT01634815
• Lead Sponsor: University Hospital, Strasbourg, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-02
• Study First Submitted QC: 2012-07-05
• Study First Posted: 2012-07-06
• Study Start: 2013-02-04
• Primary Completion: 2015-08-21
• Study Completion: 2015-08-21
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-19
• Last Update Posted: 2018-02-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
lactate group	The Edge	-

Primary Outcome Measures

Name	Time	Method
Report Capillary blood lactate To Finger Capillary blood lactate (LCO / LCD)	48 hours	Report Capillary blood lactate To Finger Capillary blood lactate (LCO / LCD) before revascularization of the lower limb in chronic critical limb ischemia (considered positive if\> 2).

Secondary Outcome Measures

Name	Time	Method
The decrease in the ratio LCO/LCD	48 hours	The decrease in the ratio LCO / LCD in the immediate aftermath of revascularization

Trial Locations

Locations (2)

Clinique de l'Orangerie; 🇫🇷 Strasbourg, France

Hôpitaux Universitaires de Strasbourg, Service d' Anesthésie Réanimation Chirurgicale; 🇫🇷 Strasbourg, France