Distal Venous Arterialisation of Ischemic Limb

Phase 3UnknownNCT01211925

Clinical Centre of Serbia30 enrolled

Overview

Distal venous arterialisation (DVA) improve outcome in patients with nonreconstructible peripheral arterial occlusive disease.

The aim of this study was to estimate validity of distal venous arterialisation (DVA) as a limb salvage procedure. This prospective randomized study reported early results of 30 unreconstructible patients with critical limb ischemia (CLI) treated during 2009 year at Clinic for vascular surgery, Clinical Center of Serbia in Belgrade. Patients were divided in two groups, 10 treated with DVA and 20 conservatively (CT) using antiplatelet drugs.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Critical Limb Ischemia

Interventions

distal venous arterialisationPROCEDURE

The investigators perform reverse revascularisation of the ischemic limb with arterial blood supply from patent in flow artery to the superficial dorsal venous arch.

AspirinDRUG

100 mg per day continuous

Eligibility

Sex: ALLMin age: 20 YearsMax age: 95 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Absence of any possibility for direct revascularisation due to extensive occlusive disease of crural and pedal arteries * Sufficient deep venous system and usable great saphenous vein as a graft for in situ bypass surgery according duplex scanning * localized infective of necrotic process up to the metatarsal level * Satisfactory general patient condition Exclusion Criteria: * advanced lower limb ischemia * venous insufficiency of lower limb

Locations (1)

Clinical Center of Serbia

Belgrade, Serbia, Serbia

Outcomes

Primary Outcomes

limb salvage

The investigators will estimate clinical improvement in patients with critical limb ischemia underwent of distal venous arterialisation. Comparative group consist patients treated with antiplatelet drugs.

Time frame: 1 year

Secondary Outcomes

lactate level in the blood of deep venous system

The investigators measure metabolic changes in the patients after distal venous arterialisation

Time frame: 1 year

Data from ClinicalTrials.gov

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