Distal Venous Arterialisation of Ischemic Limb

Phase 2

• Conditions: Critical Limb Ischemia
• Interventions: Procedure: distal venous arterialisation; Drug: Aspirin

• Registration Number: NCT01211925
• Lead Sponsor: Clinical Centre of Serbia

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2009-09
• Primary Completion: 2010-07
• Status Verified: 2010-09
• Study First Submitted: 2010-09-16
• Study First Submitted QC: 2010-09-29
• Last Update Submitted: 2010-09-29
• Study First Posted: 2010-09-30
• Last Update Posted: 2010-09-30
• Study Completion: 2011-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
critical ischemia	distal venous arterialisation	-
Control	Aspirin	Best medical treatment

Primary Outcome Measures

Name	Time	Method
limb salvage	1 year	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.

Secondary Outcome Measures

Name	Time	Method
lactate level in the blood of deep venous system	1 year	The investigators measure metabolic changes in the patients after distal venous arterialisation

Trial Locations

Locations (1)

Clinical Center of Serbia; 🇷🇸 Belgrade, Serbia