Trial Comparing Different Medical Devices for Infragenual Dilatation

• Sponsor: University Hospital, Ghent (Other)
• Overall Status: Completed
• CT.gov ID: NCT00134277
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Arms: 4
• Duration (Months): 67
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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: Sep 1, 2004
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Apr 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Primary patency after 6 months [After 6 months]

Secondary Outcome Measures

1. Proving the superiority or non-superiority of one treatment procedure to another treatment procedure [After 6 months.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Ghent	Ghent		Belgium	9000

Sponsors and Collaborators

• University Hospital, Ghent

Investigators

• Principal Investigator: Caren Randon, MD, University Hospital, Ghent

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Website University Hospital Ghent

Publications

None provided.

• Responsible Party: University Hospital, Ghent
• ClinicalTrials.gov Identifier: NCT00134277
• Other Study ID Numbers: 2004/161
• First Posted: Aug 24, 2005
• Last Update Posted: Sep 9, 2011
• Last Verified: Sep 1, 2011

• Additional relevant MeSH terms: Intermittent Claudication; Diabetic Angiopathies

Study Results

No Results Posted as of Sep 9, 2011