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

University Hospital, Strasbourg, France

Status: Terminated

Conditions: Chronic Critical Ischemia

Treatments: Procedure: The Edge

Study type: Interventional

Funder types: Other

Identifiers

NCT01634815

5244

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 1 patient group

lactate group

Experimental group

Treatment:

Procedure: The Edge