NCT Number: NCT01429714
In the Netherlands, 25.000 patients each year are diagnosed with Deep Venous Thrombosis (DVT). Elastic compression stocking (ECS) therapy reduces the incidence of post thrombotic syndrome (PTS) following DVT from 50% without ECS to 20-30% after ECS therapy for two years. It is however unclear whether all patients benefit to the same extent from this therapy or what the optimal duration of ECS therapy for individual patients should be. ECS therapy is not only costly, inconvenient and demanding but sometimes also even debilitating. Substantial costs could be saved by tailoring therapy to individual needs and as a result the quality of life for individual patients can be expected to improve.
This study aims to assess the costs and effects of tailoring the duration of ECS therapy after DVT to individual patients needs.
ECS therapy with a standard duration of 24 months will be compared with tailored ECS therapy, following an initial therapeutic period of 6 months, in patients with acute proximal DVT. The primary outcome is the percentage of patients with PTS at two year follow-up.
This is a multi-center, randomized, allocation concealed, single-blinded clinical trial.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Azienda Ospedaliera di Padova, Padua, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Individually tailored duration of elastic compression therapy,based on signs and symptoms according to the Villalta scale, following an initial therapeutic period of 6 months
Other names: Custom made flat knitted, knee length, class III stockings (Mediven ®550, ankle pressure 40 mmHg)
Elastic compression therapy with a standard duration of 24 months
Other names: Custom made flat knitted, knee length, class III stockings (Mediven ®550, ankle pressure 40 mmHg)
Time frame: At 24 months after the event of the acute DVT
Time frame: Baseline, 3, 6, 12 and 24 months
HRQOL, will be measured by questionnaires SF-36, EuroQol-5D, Veines-Qol Dutch translated
Time frame: 24 months
Time frame: 24 months
Time frame: 3, 6, 12, 24 months
Costs will include direct costs (e.g. medical therapy) and indirect costs (e.g. travel) and will be measured by case record forms, hospital data and 5 retrospective cost-questionnaires
Time frame: baseline, 24 months
Patient preferences will be elicited by conducting a discrete choice experiment (DCE)
Maastricht University Medical Center
Other
Individually Tailored Elastic Compression Therapy After Deep Venous Thrombosis in Relation to the Incidence of Post Thrombotic Syndrome, a Randomized Multicenter Trial
Acronym: IDEAL
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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