Distal Venous Arterialisation of Ischemic Limb

Distal Venous Arterialisation in the Treatment of Critical Ischemia of Lower Limb

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01211925

Enrollment

Registered

2010-09-30

Start date

2009-09-30

Completion date

2011-07-31

Last updated

2010-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Limb Ischemia

Keywords

unreconstructable peripheral arterial disease

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.

Interventions

PROCEDUREdistal venous arterialisation

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

DRUGAspirin

100 mg per day continuous

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 95 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Serbia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026