Effect of Standing, Lying and Stockings on Blood Bio-markers (v.1)
Local Endogenous Biomarkers in the Later Stages of Chronic Venous Disease Versus Controls During Gravitational Stress, Prolonged Elevation Recovery and Compression
1 other identifier
interventional
31
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2016
CompletedFirst Posted
Study publicly available on registry
January 25, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedApril 12, 2017
April 1, 2017
1.2 years
January 13, 2016
April 10, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
1 year
Study Arms (1)
SIGVARIS®. Class 2 - RAL: 23-32
EXPERIMENTALGraduated elastic compression stockings
Interventions
Below knee graduated elastic compression stocking
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Cardiac failure or orthopnoea
- Uncontrolled/active malignancy
- Significant impairment of mobility
- Connective tissue or autoimmune disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ealing Hospital, LNWH NHS Trust
Ealing, UB1 3HW, United Kingdom
Study Officials
- PRINCIPAL INVESTIGATOR
Evi Kalodiki, MD PhD FRCS
London North West Healthcare NHS Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2016
First Posted
January 25, 2016
Study Start
April 1, 2016
Primary Completion
July 1, 2017
Study Completion
July 1, 2017
Last Updated
April 12, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share