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临床试验/NCT02662127
NCT02662127Unknown不适用

Local Endogenous Biomarkers in the Later Stages of Chronic Venous Disease Versus Controls During Gravitational Stress, Prolonged Elevation Recovery and Compression

London North West Healthcare NHS Trust2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
31
试验地点
2
主要终点
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

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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
  • Significant peripheral vascular disease
  • Cardiac failure or orthopnoea
  • Uncontrolled/active malignancy
  • Significant impairment of mobility
  • Connective tissue or autoimmune disease

结局指标

主要结局

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

时间窗: 1 year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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