Compression Hosiery to Avoid Post-Thrombotic Syndrome

NCT04103112 | Terminated Results DMC

• 1 other identifier: 19CX5434
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 12

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 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.

Conditions

Deep Vein Thrombosis; Deep Vein Thrombosis Leg; Post Thrombotic Syndrome

Keywords

Deep Vein Thrombosis

Outcome Measures

Primary Outcomes (1)

• Incidence of Post Thrombotic Syndrome (PTS)

  Measured using the validated Villalta criteria

  30 months

Secondary Outcomes (6)

• Venous Ulceration Incidence

  30 months

• Employment Status

  30 months

• Change in Disease-specific and Generic Quality of Life

  18 months

• Change in Disease-specific and Generic Quality of Life

  18 months

• The Proportion of Participants Who Are Adherent to Stockings and Anticoagulants

  30 months

Study Arms (2)

Standard clinical care

NO INTERVENTION

Standard clinical care (anticoagulation) with no graduated compression stocking

Graduated compression stocking and standard clinical care

EXPERIMENTAL

A graduated compression stocking and the standard clinical care (anticoagulation)

Device: Graduated compression stocking

Interventions

Graduated compression stocking DEVICE

Compression stockings have been used safely in the UK for about 50 years. They contain an elastic fibre designed to fit tightly around the legs. These specialist stockings are tighter around the ankle, with the level of compression gradually decreasing up the garment. The pressure created by the stockings helps blood flow up the leg, allowing blood to flow freely to the heart and not pool in the leg which can result in pain and swelling.

Graduated compression stocking and standard clinical care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• University of Edinburgh: collaborator
• Universidad de Granada: collaborator
• University College, London: collaborator
• University of Manchester: collaborator

Study Sites (12)

Basildon and Thurrock University Hospitals NHS Foundation Trust

Basildon, United Kingdom

Location

Hampshire Hospitals NHS Foundation Trust

Basingstoke, United Kingdom

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, W68RF, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

Location

Kings College Hospital NHS Foundation Trust

London, United Kingdom

Location

London North West University Healthcare NHS Trust

London, United Kingdom

Location

Royal Free London NHS Foundation Trust

London, United Kingdom

Location

East Cheshire NHS Trust

Macclesfield, United Kingdom

Location

The Newcastle Upon Tyne Hospitals NHS Foundation Trust

Newcastle, United Kingdom

Location

Barking, Havering and Redbridge University Hospitals NHS Trust

Romford, United Kingdom

Location

Salisbury Hospital NHS Foundation Trust

Salisbury, United Kingdom

Location

MeSH Terms

Conditions

Venous Thrombosis; Postthrombotic Syndrome

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Venous Insufficiency

Results Point of Contact

• Title: Professor Alun Davies
• Organization: Imperial College London

a.h.davies@imperial.ac.uk

02033117320

Study Officials

• Alun H Davies

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: An independent researcher at each site will perform leg assessments blind to participant allocation. This researcher will not have been involved in recruitment, stocking provision, adherence monitoring or behavioural interventions. Participants will be encouraged to remove their stockings on the day prior to their clinic visit, they will be asked not to discuss the stockings with the independent assessor. Blinding will be assessed by asking the assessors whether the patient attended study visits wearing a stocking, and whether the patient made it known that they had been wearing a stocking or not.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: September 25, 2019
• Study Start: March 5, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 7, 2024
• Results First Posted: March 7, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (12)