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

This study has been completed.
Sponsor:
Information provided by:
Gloucestershire Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00991497
First received: October 7, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Varicose Veins
 Device: Compression bandaging

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial to Compare the Outcome of Localised Varicosity Compression for 24 Hours and 5 Days After Foam Sclerotherapy to Truncal Varices

Resource links provided by NLM:

MedlinePlus related topics: Varicose Veins
U.S. FDA Resources

Further study details as provided by Gloucestershire Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • Change in Aberdeen Varicose Vein Score from time of treatment to 2 and 6 weeks after treatment [ Time Frame: 2 and 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Burford pain score from time of treatment to 2 and 6 weeks after treatment [ Time Frame: 2 and 6 weeks ] [ Designated as safety issue: No ]
  • Change in SF-36 score from time of treatment to 6 weeks after treatment. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Target vein occlusion rate on duplex imaging at 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Number and type of complications seen [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 124
Study Start Date: January 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 24 hours compression bandaging Device: 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.
Active Comparator: 5 days compression bandaging Device: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00991497

Locations
United Kingdom
Gloucestershire Royal Hospital NHS Trust
Gloucester, Gloucestershire, United Kingdom, GL1 3NN
Sponsors and Collaborators
Gloucestershire Hospitals NHS Foundation Trust
Investigators
Principal Investigator: Jonothan J Earnshaw, FRCS, MD Gloucestershire Royal Hospital NHS Trust
  More Information

No publications provided by Gloucestershire Hospitals NHS Foundation Trust

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jonothan J Earnshaw, Gloucetershire Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00991497     History of Changes
Other Study ID Numbers: 06/Q2005/128
Study First Received: October 7, 2009
Last Updated: October 7, 2009
Health Authority: United Kingdom: National Health Service

Keywords provided by Gloucestershire Hospitals NHS Foundation Trust:
varicose veins
foam sclerotherapy
compression bandaging
duration

Additional relevant MeSH terms:
Varicose Veins
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013