NCT01429714.

Trial name or title	The IDEAL DVT Study
Methods	Study design: randomised controlled trial Allocation: randomised Endpoint classification: efficacy study Intervention model: parallel assignment Masking: single‐blind (caregiver) Primary purpose: prevention Losses to follow‐up: not available yet
Participants	Countries: The Netherlands and Italy n = 864 Inclusion criteria: Legal age (18 years) Informed consent Acute objectively documented DVT of the leg Adequate anticoagulation Exclusion criteria: Previous DVT in the affected leg Recurrent DVT in the first 6 months following inclusion Pre‐existent venous insufficiency (skin signs C4 to C6 on CEAP score or requiring ECS therapy) Contraindication for elastic compression therapy (arterial insufficiency) Active thrombolysis Life expectancy < 6 months
Interventions	All participants are advised to wear the ECS during the first 6 months after DVT Intervention group (n = 432): Duration of ECS therapy is individually tailored on the basis of Villalta scores. < 4 at both 3‐month and 6‐month follow‐up visits: ECS therapy is discontinued. ≥ 5 at 3‐month follow‐up visit and ≤ 4 at 6‐month follow‐up visit: ECS therapy for another 6 months If Villalta score at 12‐month follow‐up visit is ≤ 4, ECS therapy is discontinued. ≥ 5 at both 3‐month and 6‐month follow‐up visits: ECS therapy for a total duration of 24 months Comparison group (n = 432): ECS daily for a total duration of 2 years
Outcomes	Primary outcome: development of PTS at 24 months after DVT Secondary outcomes: ‐ Health‐related quality of life (HRQOL) ‐ Costs ‐ Recurrent thrombosis ‐ VTE‐related death during follow‐up ‐ Patient preferences
Starting date	March 2011
Contact information	Principal Investigator: Arina J Ten Cate‐Hoek, MD, PhD, MpH Maastricht University Medical Centre
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