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Compression Hosiery to Avoid Post-Thrombotic Syndrome

Compression Hosiery to Avoid Post-Thrombotic Syndrome (CHAPS)

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04103112
Acronym
CHAPS
Enrollment
152
Registered
2019-09-25
Start date
2020-03-05
Completion date
2022-12-31
Last updated
2024-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Vein Thrombosis, Deep Vein Thrombosis Leg, Post Thrombotic Syndrome

Keywords

Deep Vein Thrombosis

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.

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 and skin breakdown (ulcers) can occur, a lifelong condition called post-thrombotic syndrome. This impacts upon a person's ability to work, their confidence and independence. In most patients there is no effective treatment and they lose income from unemployment. Ulcers, if they occur, require bandaging that needs to be changed twice weekly. Treatment guidelines for deep vein thrombosis do not currently include the use of a compression stockings. They can sometimes be difficult to put on for those who cannot bend down, the stockings can slip or roll down, or become uncomfortable in hot weather. Stockings cost the National Health Service (NHS) approximately £50 every 6 months. The evidence for stockings comes from two early trials comparing patients wearing a stocking to those who did not. There was a large benefit in both these trials for wearing a stocking, with no major side effects. In 2014, a Canadian group published a trial comparing wearing a compression stocking to wearing a non-compressive stocking. The rates of post-thrombotic syndrome were identical. The Canadian trial also suggested that only half of patients actually wear stockings, one reason the trial may have shown no difference. The Canadian trial suggested that stockings did not prevent future thrombosis or help leg pain. Whilst United Kingdom National Institute for Health and Care Excellence (NICE) recommendations are to avoid stockings after deep vein thrombosis, European recommendations are to still wear them. The contradictory results of these three trials have led us to design the CHAPS trial. The aim of CHAPS is to confirm whether there is a real benefit of wearing stockings in addition to the standard treatment for deep vein thrombosis, which is blood thinning medication. Adults with a first deep vein thrombosis can join the trial. They will be randomly allocated to receive either blood thinning medication, or blood thinning medication and an additional compression stocking. This is a tight, custom fitted stocking that they will be asked to wear whilst they are awake as much as possible for between 6-30 months. Patients will be aware of which group they are in, but will be asked not to wear the stocking when they come for their assessment. This keeps the researchers impartial.

Interventions

DEVICEGraduated compression stocking

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.

Sponsors

University of Edinburgh
CollaboratorOTHER
Universidad de Granada
CollaboratorOTHER
University College, London
CollaboratorOTHER
University of Manchester
CollaboratorOTHER
Imperial College London
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Post Thrombotic Syndrome (PTS)30 monthsMeasured using the validated Villalta criteria

Secondary

MeasureTime frameDescription
Venous Ulceration Incidence30 monthsMeasured using the validated Villalta criteria
Employment Status30 monthsChange in number of days working from baseline
Change in Disease-specific and Generic Quality of Life18 monthsMeasured using VEINES-QoL scale (instrument to measure quality of life in deep venous thrombosis). Two summary scores can be computed. The VEINES-QOL summary score (25 items) provides an estimate of the overall impact of deep venous thrombosis on the patient's quality of life. The VEINES-Sym summary score (10 items) measures symptom severity. Higher scores indicate better outcomes.
The Proportion of Participants Who Are Adherent to Stockings and Anticoagulants30 monthsPatient self-report - at six months median follow up, the criteria for continuing CHAPS is equal to or over 70% of participants wearing stockings (monthly self-reported patient adherence questionnaire) for equal to or over 4 days per week in the intervention arm, along with a documented reorder of stockings within the last 6 months.
Cost-effectiveness of Stocking Prescription30 monthsIncremental cost-effectiveness ratio (ICER) from the EQ-5D questionnaire, with appropriate sensitivity analysis

Countries

United Kingdom

Participant flow

Participants by arm

ArmCount
Standard Clinical Care
Standard clinical care (anticoagulation) with no graduated compression stocking
76
Graduated Compression Stocking and Standard Clinical Care
A graduated compression stocking and the standard clinical care (anticoagulation) Graduated compression stocking: 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.
76
Total152

Baseline characteristics

CharacteristicStandard Clinical CareGraduated Compression Stocking and Standard Clinical CareTotal
Age, Continuous58.5 years
STANDARD_DEVIATION 14.2
56.2 years
STANDARD_DEVIATION 14.8
57.3 years
STANDARD_DEVIATION 14.5
Race/Ethnicity, Customized
Asian or Asian British
2 Participants8 Participants10 Participants
Race/Ethnicity, Customized
Black or Black British
3 Participants6 Participants9 Participants
Race/Ethnicity, Customized
Mixed Race/Multiple Ethnic Background
2 Participants1 Participants3 Participants
Race/Ethnicity, Customized
Other
3 Participants3 Participants6 Participants
Race/Ethnicity, Customized
White
66 Participants58 Participants124 Participants
Region of Enrollment
United Kingdom
76 participants76 participants152 participants
Sex: Female, Male
Female
20 Participants29 Participants49 Participants
Sex: Female, Male
Male
56 Participants47 Participants103 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
1 / 760 / 76
other
Total, other adverse events
5 / 766 / 76
serious
Total, serious adverse events
5 / 762 / 76

Outcome results

Primary

Incidence of Post Thrombotic Syndrome (PTS)

Measured using the validated Villalta criteria

Time frame: 30 months

ArmMeasureGroupValue (NUMBER)
Standard Clinical CareIncidence of Post Thrombotic Syndrome (PTS)Index-Leg28 Number of PTS events
Standard Clinical CareIncidence of Post Thrombotic Syndrome (PTS)Non-Index-Leg6 Number of PTS events
Graduated Compression Stocking and Standard Clinical CareIncidence of Post Thrombotic Syndrome (PTS)Index-Leg17 Number of PTS events
Graduated Compression Stocking and Standard Clinical CareIncidence of Post Thrombotic Syndrome (PTS)Non-Index-Leg9 Number of PTS events
Secondary

Change in Disease-specific and Generic Quality of Life

Measured using VEINES-QoL scale (instrument to measure quality of life in deep venous thrombosis). Two summary scores can be computed. The VEINES-QOL summary score (25 items) provides an estimate of the overall impact of deep venous thrombosis on the patient's quality of life. The VEINES-Sym summary score (10 items) measures symptom severity. Higher scores indicate better outcomes.

Time frame: 18 months

Secondary

Change in Disease-specific and Generic Quality of Life

Measured using EuroQoL EQ5D scale (European Quality of Life 5D instrument for measuring generic health status) . A health index on a score of 0 to 1 and the participants' self-rated health on a vertical score of zero to 100. Higher scores indicate better quality of life.

Time frame: 18 months

Secondary

Cost-effectiveness of Stocking Prescription

Incremental cost-effectiveness ratio (ICER) from the EQ-5D questionnaire, with appropriate sensitivity analysis

Time frame: 30 months

Secondary

Employment Status

Change in number of days working from baseline

Time frame: 30 months

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Standard Clinical CareEmployment StatusFull time34 Participants
Standard Clinical CareEmployment StatusPart time8 Participants
Standard Clinical CareEmployment StatusUnemployed7 Participants
Standard Clinical CareEmployment StatusRetired26 Participants
Standard Clinical CareEmployment StatusStudent1 Participants
Standard Clinical CareEmployment StatusMissing0 Participants
Graduated Compression Stocking and Standard Clinical CareEmployment StatusStudent0 Participants
Graduated Compression Stocking and Standard Clinical CareEmployment StatusFull time34 Participants
Graduated Compression Stocking and Standard Clinical CareEmployment StatusRetired27 Participants
Graduated Compression Stocking and Standard Clinical CareEmployment StatusPart time9 Participants
Graduated Compression Stocking and Standard Clinical CareEmployment StatusMissing1 Participants
Graduated Compression Stocking and Standard Clinical CareEmployment StatusUnemployed5 Participants
Secondary

The Proportion of Participants Who Are Adherent to Stockings and Anticoagulants

Patient self-report - at six months median follow up, the criteria for continuing CHAPS is equal to or over 70% of participants wearing stockings (monthly self-reported patient adherence questionnaire) for equal to or over 4 days per week in the intervention arm, along with a documented reorder of stockings within the last 6 months.

Time frame: 30 months

Secondary

Venous Ulceration Incidence

Measured using the validated Villalta criteria

Time frame: 30 months

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026