A Trial to Compare the Outcome of Localised Varicosity Compression for 24 Hours and 5 Days After Foam Sclerotherapy to Truncal Varices

NCT ID: NCT00991497

Last Updated: 2009-10-08

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

COMPLETED

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-01-31

Brief Summary

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The purpose of this study is to compare the results of foam treatment of varicose veins (foam sclerotherapy) in patients who wear compression bandages for 24 hours or 5 days after treatment.

Detailed Description

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Conditions

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Varicose Veins

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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24 hours compression bandaging

Group Type ACTIVE_COMPARATOR

Compression bandaging

Intervention Type DEVICE

Cotton wool padding will then be placed over the treated vein and secured in place by crepe bandaging. An above-knee TED stocking will be applied on top of this.

5 days compression bandaging

Group Type ACTIVE_COMPARATOR

Compression bandaging

Intervention Type DEVICE

Cotton wool padding will then be placed over the treated vein and secured in place by crepe bandaging. An above-knee TED stocking will be applied on top of this.

Interventions

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Compression bandaging

Cotton wool padding will then be placed over the treated vein and secured in place by crepe bandaging. An above-knee TED stocking will be applied on top of this.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Proven truncal venous incompetence (of \>1 second duration) on venous duplex scanning. (Great saphenous vein (GSV), small saphenous vein (SSV), anterior accessory thigh vein (AATV) or other major tributary).
* Agreed preference for foam sclerotherapy treatment.
* Signed consent form agreeing to be part of the trial.

Exclusion Criteria

* Total deep venous reflux.
* Known allergy to liquid sclerosant.
* Pregnancy or breast feeding.
* Arterial disease.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gloucestershire Hospitals NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Gloucetershire Hospitals NHS Foundation Trust

Principal Investigators

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Jonothan J Earnshaw, FRCS, MD

Role: PRINCIPAL_INVESTIGATOR

Gloucestershire Royal Hospital NHS Trust

Locations

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Gloucestershire Royal Hospital NHS Trust

Gloucester, Gloucestershire, United Kingdom

Site Status

Countries

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United Kingdom

References

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O'Hare JL, Stephens J, Parkin D, Earnshaw JJ. Randomized clinical trial of different bandage regimens after foam sclerotherapy for varicose veins. Br J Surg. 2010 May;97(5):650-6. doi: 10.1002/bjs.6951.

Reference Type DERIVED
PMID: 20306530 (View on PubMed)

Other Identifiers

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06/Q2005/128

Identifier Type: -

Identifier Source: org_study_id

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