Deep Vein ThrombosisPhase 3NCT00426075
Full-Leg vs Below-Knee Elastic Stockings for Prevention of the Post-Thrombotic Syndrome
A Phase 3 study testing Elastic stockings in people with Deep Vein Thrombosis, run by University of Padova at 1 site in Italy.
Trial summary
Prospective controlled randomized clinical trial. Consecutive patients with acute proximal deep vein thrombosis of the lower extremities, with or without contemporary manifestations of pulmonary embolism, are randomized to receive either a below-knee or a full-leg graduated compression (30-40 mm Hg at the ankle)… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Deep Vein Thrombosis
- What is being tested?
- Elastic stockings
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteItaly
- Study dates
- Jan 2006to Nov 2007
- Phase
- Phase 3
- 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
- First episode of proximal deep vein thrombosis, as shown by compression ultrasound
Who cannot join
- Previous ipsilateral deep vein thrombosis
- Preexisting chronic venous insufficiency
- Bilateral deep vein thrombosis
- Life expectancy lower than 1 year
- Severe arteriopathy of the lower limbs
- Known allergy to elastic stockings
- Lack of written informed consensus
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Medical and Surgical Sciences, 2nd Chair of Internal Medicine, University of Padua
Padua, Padua, 35128
About this study
Prospective controlled randomized clinical trial. Consecutive patients with acute proximal deep vein thrombosis of the lower extremities, with or without contemporary manifestations of pulmonary embolism, are randomized to receive either a below-knee or a full-leg graduated compression (30-40 mm Hg at the ankle) elastic stocking for prevention of the post-thrombotic syndrome (PTS). All patients are followed up to three years to assess the development of the PTS, defined according to a validated clinical score (the Villalta scale). The rate of PTS is compared between the two study groups. In addition, there is an assessment of patients' compliance and tolerability of the two different devices.
- Conditions
- Deep Vein Thrombosis
- Being tested
- Elastic stockings
- Keywords
- Deep vein thrombosis of the lower extremities
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elastic stockingsDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2007 (estimated)
- Study startJan 2006
- Primary completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Investigators
- Paolo Prandoni, MD, PhD, Principal investigator, Department of Medical and Surgical Sciences, University of Padua, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00426075
- Sponsor's protocol ID
- 11/98
- Status last verified
- Jun 2008
- First submitted
- 23 Jan 2007
- Last updated
- 10 Jun 2008
- Results posted
- No
Publications
Prandoni P, Noventa F, Quintavalla R, Bova C, Cosmi B, Siragusa S, Bucherini E, Astorri F, Cuppini S, Dalla Valle F, Lensing AW, Prins MH, Villalta S; Canano Investigators. Thigh-length versus below-knee compression elastic stockings for prevention of the postthrombotic syndrome in patients with proximal-venous thrombosis: a randomized trial. Blood. 2012 Feb 9;119(6):1561-5. doi: 10.1182/blood-2011-11-391961. Epub 2011 Dec 16.
PubMed 22180438
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Full-Leg vs Below-Knee Elastic Stockings for Prevention of the Post-Thrombotic Syndrome
- ClinicalTrials.gov ID
- NCT00426075
- Acronym / sponsor ID
- 11/98
- Conditions
- Deep Vein Thrombosis
- Keywords
- Deep vein thrombosis of the lower extremities
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Nov 2007 (actual)
- First posted
- 24 Jan 2007 (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.
Prospective controlled randomized clinical trial. Consecutive patients with acute proximal deep vein thrombosis of the lower extremities, with or without contemporary manifestations of pulmonary embolism, are randomized to receive either a below-knee or a full-leg graduated compression (30-40 mm Hg at the ankle) elastic stocking for prevention of the post-thrombotic syndrome (PTS). All patients are followed up to three years to assess the development of the PTS, defined according to a validated clinical score (the Villalta scale). The rate of PTS is compared between the two study groups. In addition, there is an assessment of patients' compliance and tolerability of the two different devices.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- First episode of proximal deep vein thrombosis, as shown by compression ultrasound
Key exclusion criteria (7 listed)
- Previous ipsilateral deep vein thrombosis
- Preexisting chronic venous insufficiency
- Bilateral deep vein thrombosis
- Life expectancy lower than 1 year
- Severe arteriopathy of the lower limbs
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 |
|---|---|---|
| Elastic stockings | Device | – |
Primary outcome
Not reported in the source record.
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 10 Jun 2008.
- Derived from this study: PubMed 22180438Prandoni P, Noventa F, Quintavalla R, Bova C, Cosmi B, Siragusa S, Bucherini E, Astorri F, Cuppini S, Dalla Valle F, Lensing AW, Prins MH, Villalta S; Canano Investigators. Thigh-length versus below-knee compression elastic stockings for prevention of the postthrombotic syndrome in patients with proximal-venous thrombosis: a randomized trial. Blood. 2012 Feb 9;119(6):1561-5. doi: 10.1182/blood-2011-11-391961. Epub 2011 Dec 16.
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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.
Paolo Prandoni, MD, PhD principal investigator
Department of Medical and Surgical Sciences, University of Padua, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Elastic stockings in people with Deep Vein Thrombosis, run by University of Padova at 1 site in Italy.
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 1 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 10 Jun 2008. 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 Italy. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00426075, which also lists 1 linked publication.
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 10 Jun 2008.