Status:
TERMINATED
Compression Hosiery to Avoid Post-Thrombotic Syndrome
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
University of Edinburgh
Universidad de Granada
Conditions:
Deep Vein Thrombosis
Deep Vein Thrombosis Leg
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
Every year 1 in 1000 persons in the United Kingdom are diagnosed with a blood clot in the leg veins (deep vein thrombosis). In just under half of those with deep vein thrombosis, leg pain, swelling an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT04103112
Start Date
March 5 2020
End Date
December 31 2022
Last Update
March 7 2024
Active Locations (12)
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1
Basildon and Thurrock University Hospitals NHS Foundation Trust
Basildon, United Kingdom
2
Hampshire Hospitals NHS Foundation Trust
Basingstoke, United Kingdom
3
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
4
Imperial College Healthcare NHS Trust
London, United Kingdom, W68RF