Diabetic AngiopathiesNCT00134277
Trial Comparing Different Medical Devices for Infragenual Dilatation
A study testing Infragenual dilatation, Infragenual dilatation with stenting and Infragenual dilatation with cutting balloon in people with Diabetic Angiopathies and Intermittent Claudication, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
This study is a comparison of different medical devices for infragenual dilatation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Angiopathies, Intermittent Claudication
- What is being tested?
- Infragenual dilatation, Infragenual dilatation with stenting and Infragenual dilatation with cutting balloon
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2004to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diabetes type I or II with diabetic angiopathy stage IIb to IV (Fontaine)
- Atherosclerotic patients with distal angiopathy stage IIb to IV (Fontaine)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomised Comparing Trial Between an Infragenual Dilatation (ID), an ID With Stenting, an ID With Cutting Balloon and Laser Therapy
This study is a comparison of different medical devices for infragenual dilatation.
Read the 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).
- Conditions
- Diabetic Angiopathies, Intermittent Claudication
- Being tested
- Infragenual dilatation, Infragenual dilatation with stenting, Infragenual dilatation with cutting balloon, Laser therapy
- Medical subject headings
- Diabetic Angiopathies, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infragenual dilatationProcedure or surgery
Infragenual dilatation
Infragenual dilatation with stentingProcedure or surgery
Infragenual dilatation with stenting
Infragenual dilatation with cutting balloonProcedure or surgery
Infragenual dilatation with cutting balloon
Laser therapyProcedure or surgery
Laser therapy
| Study group | Role | What they receive |
|---|---|---|
| Infragenual dilatation with stenting | Active comparator | Not described Receives: Procedure: Infragenual dilatation with stenting |
| Infragenual dilatation with cutting balloon | Active comparator | Not described Receives: Procedure: Infragenual dilatation with cutting balloon |
| Laser therapy | Active comparator | Not described Receives: Procedure: Laser therapy |
| Infragenual dilatation | Placebo comparator | Not described Receives: Procedure: Infragenual dilatation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency after 6 months
Measured: After 6 months
Secondary outcomes (1)
Proving the superiority or non-superiority of one treatment procedure to another treatment procedure
Measured: After 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2005 (estimated)
- Study startSep 2004
- Primary completionJan 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic AngiopathiesStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caren Randon, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00134277
- Sponsor's protocol ID
- 2004/161
- Status last verified
- Sep 2011
- First submitted
- 23 Aug 2005
- Last updated
- 9 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomised Comparing Trial Between an Infragenual Dilatation (ID), an ID With Stenting, an ID With Cutting Balloon and Laser Therapy
- ClinicalTrials.gov ID
- NCT00134277
- Acronym / sponsor ID
- 2004/161
- Conditions
- Diabetic Angiopathies, Intermittent Claudication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Sep 2004
- Primary completion
- Jan 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 24 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Infragenual dilatation with stenting | Active comparator | Procedure: Infragenual dilatation with stenting |
| Infragenual dilatation with cutting balloon | Active comparator | Procedure: Infragenual dilatation with cutting balloon |
| Laser therapy | Active comparator | Procedure: Laser therapy |
| Infragenual dilatation | Placebo comparator | Procedure: Infragenual dilatation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Diabetes type I or II with diabetic angiopathy stage IIb to IV (Fontaine)
- Atherosclerotic patients with distal angiopathy stage IIb to IV (Fontaine)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infragenual dilatationInfragenual dilatation | Procedure or surgery | Infragenual dilatation |
| Infragenual dilatation with stentingInfragenual dilatation with stenting | Procedure or surgery | Infragenual dilatation with stenting |
| Infragenual dilatation with cutting balloonInfragenual dilatation with cutting balloon | Procedure or surgery | Infragenual dilatation with cutting balloon |
| Laser therapyLaser therapy | Procedure or surgery | Laser therapy |
Primary outcome
Primary patency after 6 months
Time frame: After 6 months
1 secondary outcome
Proving the superiority or non-superiority of one treatment procedure to another treatment procedure
Time frame: After 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2011.
- Website University Hospital GhentLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caren Randon, MD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infragenual dilatation, Infragenual dilatation with stenting and Infragenual dilatation with cutting balloon in people with Diabetic Angiopathies and Intermittent Claudication, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary patency after 6 months (time frame: After 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2011.