TerminatedNot Applicable

Compression Hosiery to Avoid Post-Thrombotic Syndrome

Stopped: At the request of the study's funders (NIHR-HTA) the study was terminated early due to poor recruitment in the context of the COVID-19 pandemic and unprecedented pressures faced by the NHS.

United Kingdom152 participantsStarted 2020-03-05

Plain-language summary

Patients with a deep vein thrombosis (DVT) may develop long-term symptoms, e.g. lifelong leg pain, skin changes and occasionally ulceration, known as post-thrombotic syndrome (PTS). This affects about half of people with a history of DVT. This randomised study aims to show whether the regular use of a compression stocking after DVT in the leg, prevents long-term pain, swelling and ulceration. Currently small trials show varied results and a large trial is required to answer the question.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Symptomatic presentation of first deep vein thrombosis, \<2 weeks from diagnosis * Imaging confirmed, lower limb deep vein thrombosis (popliteal, femoral, iliac or combination) * Ability to give informed consent * Age 18 or over Exclusion Criteria: * Life expectancy \< 2 years * Contraindication to wearing graduated compression stockings * Previously intolerant of or already wearing graduated compression stockings for more than 1 month. * Ankle brachial pressure index (ABPI) \<0.8 or pedal pulses absent * Bilateral deep vein thrombosis * Previous chronic venous insufficiency (patients with existing chronic skin changes or ulceration, defined as C4,5,6 by Clinical Etiological Anatomical Pathophysiological (CEAP) classification) * Pre-existing post thrombotic syndrome, significant leg pain (e.g. knee arthritis, spinal claudication) or oedema (e.g. lymphoedema). * Newly diagnosed cancer, metastatic cancer, or cancer undergoing active treatment or palliation * Contraindication to anticoagulation * Known allergy to fabric in compression stockings

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Post Thrombotic Syndrome (PTS)

Timeframe: 30 months

Trial details

NCT IDNCT04103112

SponsorImperial College London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-31

Results submitted2023-07-21

View on ClinicalTrials.gov More Deep Vein Thrombosis trials