Distal Venous Arterialisation of Ischemic Limb

September 29, 2010 updated by: Clinical Centre of Serbia

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Serbia
      • Belgrade, Serbia, 11000
        • Clinical Center of Serbia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 91 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: critical ischemia
Procedure: distal 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.
Other Names:
  • Venous arterialisation, arteriovenous reversal
No Intervention: Control
Best medical treatment
Drug: Aspirin
100 mg per day continuous

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
limb salvage
Time Frame: 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.
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinical Centre of Serbia

Collaborators

University of California, Los Angeles

Investigators

  • Principal Investigator: Predrag Vl Djoric, MD, Clinical Center of Serbia in Belgrade, Clinic for Vascular and Endovascular Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

July 1, 2010

Study Completion (Anticipated)

July 1, 2011

Study Registration Dates

First Submitted

September 16, 2010

First Submitted That Met QC Criteria

September 29, 2010

First Posted (Estimate)

September 30, 2010

Study Record Updates

Last Update Posted (Estimate)

September 30, 2010

Last Update Submitted That Met QC Criteria

September 29, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 440/III-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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