Elastic Compression in Chronic Venous Disease

Study Overview
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Brief Summary
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Patients with chronic venous disease causing pain or ache will be randomised into two groups, active stockings (18-21 mmHg) or placebo stockings

Detailed Description
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Patients with chronic venous disease causing pain or ache satisfying the inclusion and exclusion criteria will be randomised into two groups, active stockings (18-21 mmHg) or placebo stockings. The primary outcome of the study (pain/ache scored using a visual analogue scale) and a number of secondary symptoms, signs and rVCSS (revised Venous Clinical Severity Score) will be obtained at baseline and after one week of wearing the active or placebo stocking.

Official Title
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Randomised Trial Comparing the Effectiveness of Elastic Compression in Treating Chronic Venous Disease (CEAP C2-C5)

Conditions
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Varicosity

Intervention / Treatment
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* Device: Elastic stockings
* Device: Placebo stockings


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary varicose veins causing pain/ache located only at the calf level Exclusion Criteria: Venous ulceration Dermatitis Itching Superficial vein thrombosis Peripheral arterial disease Symptoms of non-venous origin Previous use of elastic stockings

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Elastic stockings<br>Class 1 elastic stockings (18-21 mmHg) | Device: Elastic stockings<br>* Use of elastic stockings to alleviate patient symptoms<br>|
| Placebo Comparator: Placebo stockings<br>Placebo stockings (0 mmHg) | Device: Placebo stockings<br>* Placebo stocking with pressure applied to the legs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain/ache assessed using a visual analogue scale (0-10) | Patients with varicose veins often complain for dull pain of ache. This will be assessed using a visual analogue scale (0-10) | One week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| revised Venous Clinical Severity Score (rVCSS) | revised Venous Clinical Severity Score | One week | 
| Heaviness assessed using a visual analogue scale (0-10) | Patients with varicose veins often complain for heaviness. This will be assessed using a visual analogue scale (0-10) | One week | 
| Night cramps assessed using a visual analogue scale (0-10) | Patients with varicose veins often complain for night cramps. These will be assessed using a visual analogue scale (0-10) | One week | 
| Swelling sensation assessed using a visual analogue scale (0-10) | Patients with varicose veins often complain for sensation of swelling. This will be assessed using a visual analogue scale (0-10) | One week | 
| Burning sensation assessed using a visual analogue scale (0-10) | Patients with varicose veins often complain for burning sensation. This will be assessed using a visual analogue scale (0-10) | One week | 
| Paresthesia assessed using a visual analogue scale (0-10) | Patients with varicose veins often complain for paresthesia. This will be assessed using a visual analogue scale (0-10) | One week | 
| Restless legs assessed using a visual analogue scale (0-10) | Patients with varicose veins often complain for restless legs. This symptom will be assessed using a visual analogue scale (0-10) | One week | 
| throbbing assessed using a visual analogue scale (0-10) | Patients with varicose veins often complain for throbbing of their varicose veins. This will be assessed using a visual analogue scale (0-10) | One week | 
| insomnia assessed using a visual analogue scale (0-10) | Patients with varicose veins often complain for insomnia. This will be assessed using a visual analogue scale (0-10) | One week | 
| Ankle circumference | This will be measured just above the malleoli, at the smallest point. | One week |