Effect of Standing, Lying and Stockings on Blood Bio-markers (v.1)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Training of a Artificial Intelligence Model to Detect Venous Diseases Using PPG Technology

NCT06433024

Venous Disease

NOT_YET_RECRUITING

Study to Find Out the Timing for the Optimal Imaging of Varicose Veins Using Infrared Thermography.

NCT07334028

Varicose Veins Leg

RECRUITING

A Comparison of Specialized Versus Standard Compression After Saphenous Ablation

NCT01332838

Varicose Veins

UNKNOWN NA

Evaluation of Pain Associated With Chronic Venous Insufficiency

NCT04794712

Chronic Venous Insufficiency Varicose Veins of Lower Limb

UNKNOWN

Lower Extremity Venous Hemodynamics in Obese Patients Without Clinically Significant Venous Disease

NCT00554541

Obesity Peripheral Arterial Disease

TERMINATED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

1. 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.
2. 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.
3. 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.
4. 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

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Venous Insufficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SIGVARIS®. Class 2 - RAL: 23-32

Graduated elastic compression stockings

Group Type EXPERIMENTAL

SIGVARIS® Class 2 - RAL: 23-32.

Intervention Type DEVICE

Below knee graduated elastic compression stocking

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SIGVARIS® Class 2 - RAL: 23-32.

Below knee graduated elastic compression stocking

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Patients from the vascular clinic at Ealing Hospital with venous disease

1. Venous skin changes including lipodermatosclerosis and pigmentation
2. Significant reflux \>0.5 seconds on duplex
2. Volunteers from NHS healthcare workers or the general public

1. Absence of venous symptoms
2. Freedom from varicose veins or skin changes

Exclusion Criteria

1. Previous treatment for varicose veins on the study leg
2. Previous history of deep or superficial vein thrombosis
3. Receiving anticoagulation
4. Haematological disorders of coagulation or thrombosis
5. Pregnancy
6. Significant peripheral vascular disease
7. Cardiac failure or orthopnoea
8. Uncontrolled/active malignancy
9. Significant impairment of mobility
10. Connective tissue or autoimmune disease

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes