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Distal Venous Arterialisation of Ischemic Limb

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ClinicalTrials.gov Identifier: NCT01211925
Recruitment Status : Unknown
Verified September 2010 by Clinical Centre of Serbia.
Recruitment status was:  Active, not recruiting
First Posted : September 30, 2010
Last Update Posted : September 30, 2010
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by:
Clinical Centre of Serbia

Tracking Information
First Submitted Date  ICMJE September 16, 2010
First Posted Date  ICMJE September 30, 2010
Last Update Posted Date September 30, 2010
Study Start Date  ICMJE September 2009
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2010)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2010)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Distal Venous Arterialisation of Ischemic Limb
Official Title  ICMJE Distal Venous Arterialisation in the Treatment of Critical Ischemia of Lower Limb
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Critical Limb Ischemia
Intervention  ICMJE
  • 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 Name: Venous arterialisation, arteriovenous reversal
  • Drug: Aspirin
    100 mg per day continuous
Study Arms  ICMJE
  • Experimental: critical ischemia
    Intervention: Procedure: distal venous arterialisation
  • No Intervention: Control
    Best medical treatment
    Intervention: Drug: Aspirin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: September 29, 2010)
30
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Serbia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01211925
Other Study ID Numbers  ICMJE 440/III-3
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Clinic for Vascular and Endovascular Surgery, Clinical Center of Serbia, Belgrade
Study Sponsor  ICMJE Clinical Centre of Serbia
Collaborators  ICMJE University of California, Los Angeles
Investigators  ICMJE
Principal Investigator: Predrag Vl Djoric, MD Clinical Center of Serbia in Belgrade, Clinic for Vascular and Endovascular Surgery
PRS Account Clinical Centre of Serbia
Verification Date September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP