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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

October 7, 2009
October 7, 2009
January 2007
January 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Trial to Compare the Outcome of Localised Varicosity Compression for 24 Hours and 5 Days After Foam Sclerotherapy to Truncal Varices
A Randomised Controlled Trial to Compare the Outcome of Localised Varicosity Compression for 24 Hours and 5 Days After Foam Sclerotherapy to Truncal Varices

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Varicose Veins
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: 24 hours compression bandaging
    Intervention: Device: Compression bandaging
  • Active Comparator: 5 days compression bandaging
    Intervention: Device: Compression bandaging
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
124
January 2008
January 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00991497
06/Q2005/128
Yes
Jonothan J Earnshaw, Gloucetershire Hospitals NHS Foundation Trust
Gloucestershire Hospitals NHS Foundation Trust
Not Provided
Principal Investigator: Jonothan J Earnshaw, FRCS, MD Gloucestershire Royal Hospital NHS Trust
Gloucestershire Hospitals NHS Foundation Trust
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP