Elastic Compression in Chronic Venous Disease

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-04-30

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

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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.

Conditions

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Varicosity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Elastic stockings

Class 1 elastic stockings (18-21 mmHg)

Group Type ACTIVE_COMPARATOR

Elastic stockings

Intervention Type DEVICE

Use of elastic stockings to alleviate patient symptoms

Placebo stockings

Placebo stockings (0 mmHg)

Group Type PLACEBO_COMPARATOR

Placebo stockings

Intervention Type DEVICE

Placebo stocking with pressure applied to the legs

Interventions

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Elastic stockings

Use of elastic stockings to alleviate patient symptoms

Intervention Type DEVICE

Placebo stockings

Placebo stocking with pressure applied to the legs

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No