Chronic Venous InsufficiencyNCT02662127
Effect of Standing, Lying and Stockings on Blood Bio-markers (v.1)
A study testing SIGVARIS® Class 2 - RAL: 23-32. in people with Chronic Venous Insufficiency, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
Venous disease effects 25% of the population and most healthy people experience venous symptoms after standing for too long. The prime function of leg veins is drainage. Failure leads to a condition called chronic venous insufficiency (CVI) with leg pain, heaviness, swelling, varicose veins, ankle skin changes, eczema… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Venous Insufficiency
- What is being tested?
- SIGVARIS® Class 2 - RAL: 23-32.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients from the vascular clinic at Ealing Hospital with venous disease
- Venous skin changes including lipodermatosclerosis and pigmentation
- Significant reflux >0.5 seconds on duplex
- Volunteers from NHS healthcare workers or the general public
- Absence of venous symptoms
- Freedom from varicose veins or skin changes
Who cannot join
- Previous treatment for varicose veins on the study leg
- Previous history of deep or superficial vein thrombosis
- Receiving anticoagulation
- Haematological disorders of coagulation or thrombosis
- Pregnancy
- Significant peripheral vascular disease
Show all 10Show fewer
- Cardiac failure or orthopnoea
- Uncontrolled/active malignancy
- Significant impairment of mobility
- Connective tissue or autoimmune disease
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Ealing Hospital, LNWH NHS Trust
Ealing, UB1 3HW
Chris Dr Lattimer, MD, c.lattimer09@imperial.ac.uk
Evi Dr Kalodiki, MD
About this study
Official title: Local Endogenous Biomarkers in the Later Stages of Chronic Venous Disease Versus Controls During Gravitational Stress, Prolonged Elevation Recovery and Compression
Venous disease effects 25% of the population and most healthy people experience venous symptoms after standing for too long. The prime function of leg veins is drainage. Failure leads to a condition called chronic venous insufficiency (CVI) with leg pain, heaviness, swelling, varicose veins, ankle skin changes, eczema and occasionally venous ulcers. The aim of the study is to identify blood components (biomarkers) that occur during the damaging phase of standing versus the healing phases of lying recovery and with medical compression stockings. This will be achieved by taking a blood sample from the ankle region at 3 separate visits (days) to the vascular laboratory at Ealing Hospital. The first visit will be after supervised standing for 1 hour. The second after supervised lying and the third standing whilst wearing a medical compression stocking. Healthy volunteers will be compared to patients with advanced CVI.
The potential importance to patients and the public is threefold. Firstly, biomarker profiles will be obtained in each of the 3 states to increase understanding in the cellular mechanisms of damage and recovery. In this way "bad" and "good" biomarkers can be identified. Secondly, drug treatments may develop from this research to adjust biomarkers towards a favourable profile. Thirdly, the success of treating CVI with surgery, venous intervention or compression can be monitored. Whilst it is known that relief of gravitational stress is the treatment for all forms of CVI, the mechanisms of repair and its discrimination from damage have yet to be identified.
Read the detailed description
It is well known that graduated elastic compression stockings (GECs) provide a favourable environment by off-setting the damaging effects of dependency, reducing leg oedema, preventing leg ulceration and in symptom relief. On a haemodynamic level, their mechanism of action in augmenting the venous return has been quantified. However, on a molecular level, their action in modulating local endogenous biomarkers towards a favourable profile is poorly understood. This requires further investigation.
Our hypothesis is that there are two types of biomarkers: (i) damaging inflammatory biomarkers which are increased after prolonged gravitational dependency, (i) healing reparative biomarkers which are increased after prolonged elevation recovery. Local venous blood samples draining the area of investigation may be more representative of loco-regional processes than systemic blood samples from the arm.
This is a single centre, collaborative, interventional, controlled, proof-of-concept trial.
The primary aim of this study is to investigate the effect of GEC stockings on modulating biomarkers towards a healing profile.
Planned interventions:
There will be 4 study visits per subject.
- Recruitment, patient selection, distribution of information leaflets and consent form, explanation of the demands of the study, claiming of expenses, duplex scanning and visit scheduling.
- Formal consent. Blood test. The stage of "damage" will be in the afternoon after standing all morning plus an hour of extra standing in the laboratory.
- Blood test. The stage of "healing" will be in the morning after nocturnal sleep plus an hour of extra elevation (20 degrees elevated from supine) in the laboratory.
- Blood test. The stage of "treatment" will be from the effects of a class II below knee stocking after standing all morning plus an hour of extra standing in the laboratory.
All venous blood will be taken from the ankle region. The samples will be taken during a gravitational stress, after elevation recovery and after the therapeutic effect of the compression stocking. These specifications must be met with due care and diligence to ensure that the results are meaningful. The samples will be collected in citrated tubes, centrifuged at 5,000 rpm for 10 minutes to achieve platelet poor plasma and stored at -20 degrees for batch analysis.
Proposed biomarkers for quantification:
Radox (IL-2, IL-4, IL-6, IL-8, IL-10, VEGF, IFNγ, TNFα, IL-1α, IL-1β, MCP-1, EGF) and D-dimer.
Matrix metalloproteinases (MMP-1, MMP-2, MMP-3, MMP-7, MMP-8, MMP-9, MMP-10, MMP-12 and MMP-13) and also 4 tissue inhibitors of MMPs (TIMP-1, TIMP-2, TIMP-3 and TIMP-4).
- Conditions
- Chronic Venous Insufficiency
- Being tested
- SIGVARIS® Class 2 - RAL: 23-32.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIGVARIS® Class 2 - RAL: 23-32.Device
Below knee graduated elastic compression stocking
| Study group | Role | What they receive |
|---|---|---|
| SIGVARIS®. Class 2 - RAL: 23-32 | Experimental | Graduated elastic compression stockings Receives: Device: SIGVARIS® Class 2 - RAL: 23-32. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of biomarkers which decrease greater than 20% of the baseline level as a result of the interventions of (i) lying down and with a (ii) stocking
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2016 (estimated)
- Study startApr 2016
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Venous InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London North West Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evi Kalodiki, MD PhD FRCS, Principal investigator, London North West Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02662127
- Sponsor's protocol ID
- 198127
- Status last verified
- Apr 2017
- First submitted
- 13 Jan 2016
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Endogenous Biomarkers in the Later Stages of Chronic Venous Disease Versus Controls During Gravitational Stress, Prolonged Elevation Recovery and Compression
- ClinicalTrials.gov ID
- NCT02662127
- Acronym / sponsor ID
- 198127
- Conditions
- Chronic Venous Insufficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- London North West Healthcare NHS TrustUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 25 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Venous disease effects 25% of the population and most healthy people experience venous symptoms after standing for too long. The prime function of leg veins is drainage. Failure leads to a condition called chronic venous insufficiency (CVI) with leg pain, heaviness, swelling, varicose veins, ankle skin changes, eczema and occasionally venous ulcers. The aim of the study is to identify blood components (biomarkers) that occur during the damaging phase of standing versus the healing phases of lying recovery and with medical compression stockings. This will be achieved by taking a blood sample from the ankle region at 3 separate visits (days) to the vascular laboratory at Ealing Hospital. The first visit will be after supervised standing for 1 hour. The second after supervised lying and the third standing whilst wearing a medical compression stocking. Healthy volunteers will be compared to patients with advanced CVI.
The potential importance to patients and the public is threefold. Firstly, biomarker profiles will be obtained in each of the 3 states to increase understanding in the cellular mechanisms of damage and recovery. In this way "bad" and "good" biomarkers can be identified. Secondly, drug treatments may develop from this research to adjust biomarkers towards a favourable profile. Thirdly, the success of treating CVI with surgery, venous intervention or compression can be monitored. Whilst it is known that relief of gravitational stress is the treatment for all forms of CVI, the mechanisms of repair and its discrimination from damage have yet to be identified.
Detailed description
It is well known that graduated elastic compression stockings (GECs) provide a favourable environment by off-setting the damaging effects of dependency, reducing leg oedema, preventing leg ulceration and in symptom relief. On a haemodynamic level, their mechanism of action in augmenting the venous return has been quantified. However, on a molecular level, their action in modulating local endogenous biomarkers towards a favourable profile is poorly understood. This requires further investigation.
Our hypothesis is that there are two types of biomarkers: (i) damaging inflammatory biomarkers which are increased after prolonged gravitational dependency, (i) healing reparative biomarkers which are increased after prolonged elevation recovery. Local venous blood samples draining the area of investigation may be more representative of loco-regional processes than systemic blood samples from the arm.
This is a single centre, collaborative, interventional, controlled, proof-of-concept trial.
The primary aim of this study is to investigate the effect of GEC stockings on modulating biomarkers towards a healing profile.
Planned interventions:
There will be 4 study visits per subject.
- Recruitment, patient selection, distribution of information leaflets and consent form, explanation of the demands of the study, claiming of expenses, duplex scanning and visit scheduling.
- Formal consent. Blood test. The stage of "damage" will be in the afternoon after standing all morning plus an hour of extra standing in the laboratory.
- Blood test. The stage of "healing" will be in the morning after nocturnal sleep plus an hour of extra elevation (20 degrees elevated from supine) in the laboratory.
- Blood test. The stage of "treatment" will be from the effects of a class II below knee stocking after standing all morning plus an hour of extra standing in the laboratory.
All venous blood will be taken from the ankle region. The samples will be taken during a gravitational stress, after elevation recovery and after the therapeutic effect of the compression stocking. These specifications must be met with due care and diligence to ensure that the results are meaningful. The samples will be collected in citrated tubes, centrifuged at 5,000 rpm for 10 minutes to achieve platelet poor plasma and stored at -20 degrees for batch analysis.
Proposed biomarkers for quantification:
Radox (IL-2, IL-4, IL-6, IL-8, IL-10, VEGF, IFNγ, TNFα, IL-1α, IL-1β, MCP-1, EGF) and D-dimer.
Matrix metalloproteinases (MMP-1, MMP-2, MMP-3, MMP-7, MMP-8, MMP-9, MMP-10, MMP-12 and MMP-13) and also 4 tissue inhibitors of MMPs (TIMP-1, TIMP-2, TIMP-3 and TIMP-4).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SIGVARIS®. Class 2 - RAL: 23-32 | Experimental | Device: SIGVARIS® Class 2 - RAL: 23-32.Graduated elastic compression stockings |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients from the vascular clinic at Ealing Hospital with venous disease
- Volunteers from NHS healthcare workers or the general public
Key exclusion criteria (10 listed)
- Previous treatment for varicose veins on the study leg
- Previous history of deep or superficial vein thrombosis
- Receiving anticoagulation
- Haematological disorders of coagulation or thrombosis
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIGVARIS® Class 2 - RAL: 23-32.Below knee graduated elastic compression stocking | Device | SIGVARIS®. Class 2 - RAL: 23-32 |
Primary outcome
Number of biomarkers which decrease greater than 20% of the baseline level as a result of the interventions of (i) lying down and with a (ii) stocking
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evi Kalodiki, MD PhD FRCS principal investigator
London North West Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SIGVARIS® Class 2 - RAL: 23-32. in people with Chronic Venous Insufficiency, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christopher R Lattimer, MBBS FRCS MS FdIT PhD (07960502253, c.lattimer9@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of biomarkers which decrease greater than 20% of the baseline level as a result of the interventions of (i) lying down and with a (ii) stocking (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2017.