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Trial record 3 of 848 for:    "Diabetic Angiopathies"

Trial Comparing Different Medical Devices for Infragenual Dilatation

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ClinicalTrials.gov Identifier: NCT00134277
Recruitment Status : Completed
First Posted : August 24, 2005
Last Update Posted : September 9, 2011
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent

Brief Summary:
This study is a comparison of different medical devices for infragenual dilatation.

Condition or disease Intervention/treatment Phase
Diabetic Angiopathies Intermittent Claudication Procedure: Infragenual dilatation Procedure: Infragenual dilatation with stenting Procedure: Infragenual dilatation with cutting balloon Procedure: Laser therapy Not Applicable

Detailed Description:
Dilatation and recanalisation of the distal veins (infragenual popliteal artery, tibiofibular trunc, posterior tibial artery, anterior tibial artery) by classical balloon dilatation or cutting balloon with or without stenting or by endovascular laser. This intervention happens only once; the duration of the intervention depends on the procedure and the original injuries(30 - 120 minutes).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomised Comparing Trial Between an Infragenual Dilatation (ID), an ID With Stenting, an ID With Cutting Balloon and Laser Therapy
Study Start Date : September 2004
Actual Primary Completion Date : January 2009
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Infragenual dilatation with stenting Procedure: Infragenual dilatation with stenting
Infragenual dilatation with stenting
Active Comparator: Infragenual dilatation with cutting balloon Procedure: Infragenual dilatation with cutting balloon
Infragenual dilatation with cutting balloon
Active Comparator: Laser therapy Procedure: Laser therapy
Laser therapy
Placebo Comparator: Infragenual dilatation Procedure: Infragenual dilatation
Infragenual dilatation



Primary Outcome Measures :
  1. Primary patency after 6 months [ Time Frame: After 6 months ]

Secondary Outcome Measures :
  1. Proving the superiority or non-superiority of one treatment procedure to another treatment procedure [ Time Frame: After 6 months. ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diabetes type I or II with diabetic angiopathy stage IIb to IV (Fontaine)
  • Atherosclerotic patients with distal angiopathy stage IIb to IV (Fontaine)

Exclusion Criteria:

  • Acute ischemia
  • Multisegmentaric damage above the knee
  • Sepsis: acute respiratory distress syndrome (ARDS), C-reactive protein (CRP) > 30, white blood cell (WBC) > 25,000
  • Acute myocardial infarction (AMI) during the last 14 days
  • Operative contraindication
  • Life expectancy < 2 years
  • Blue toe syndrome (micro-embolisation)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00134277


Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Caren Randon, MD University Hospital, Ghent

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00134277     History of Changes
Other Study ID Numbers: 2004/161
First Posted: August 24, 2005    Key Record Dates
Last Update Posted: September 9, 2011
Last Verified: September 2011

Additional relevant MeSH terms:
Intermittent Claudication
Diabetic Angiopathies
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases