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Trial Comparing Different Medical Devices for Infragenual Dilatation

Primary Purpose

Diabetic Angiopathies, Intermittent Claudication

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Infragenual dilatation
Infragenual dilatation with stenting
Infragenual dilatation with cutting balloon
Laser therapy
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Angiopathies

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University Hospital Ghent

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Infragenual dilatation with stenting

Infragenual dilatation with cutting balloon

Laser therapy

Infragenual dilatation

Arm Description

Outcomes

Primary Outcome Measures

Primary patency after 6 months

Secondary Outcome Measures

Proving the superiority or non-superiority of one treatment procedure to another treatment procedure

Full Information

First Posted
August 23, 2005
Last Updated
September 8, 2011
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT00134277
Brief Title
Trial Comparing Different Medical Devices for Infragenual Dilatation
Official Title
Prospective Randomised Comparing Trial Between an Infragenual Dilatation (ID), an ID With Stenting, an ID With Cutting Balloon and Laser Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Angiopathies, Intermittent Claudication

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Infragenual dilatation with stenting
Arm Type
Active Comparator
Arm Title
Infragenual dilatation with cutting balloon
Arm Type
Active Comparator
Arm Title
Laser therapy
Arm Type
Active Comparator
Arm Title
Infragenual dilatation
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
Infragenual dilatation
Intervention Description
Infragenual dilatation
Intervention Type
Procedure
Intervention Name(s)
Infragenual dilatation with stenting
Intervention Description
Infragenual dilatation with stenting
Intervention Type
Procedure
Intervention Name(s)
Infragenual dilatation with cutting balloon
Intervention Description
Infragenual dilatation with cutting balloon
Intervention Type
Procedure
Intervention Name(s)
Laser therapy
Intervention Description
Laser therapy
Primary Outcome Measure Information:
Title
Primary patency after 6 months
Time Frame
After 6 months
Secondary Outcome Measure Information:
Title
Proving the superiority or non-superiority of one treatment procedure to another treatment procedure
Time Frame
After 6 months.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caren Randon, MD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Links:
URL
http://www.uzgent.be
Description
Website University Hospital Ghent

Learn more about this trial

Trial Comparing Different Medical Devices for Infragenual Dilatation

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