Back to resultsA Trial to Compare the Outcome of Localised Varicosity Compression for 24 Hours and 5 Days After Foam Sclerotherapy to Truncal Varices
Primary Purpose
Varicose Veins
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Compression bandaging
Sponsored by
About this trial
This is an interventional treatment trial for Varicose Veins focused on measuring varicose veins, foam sclerotherapy, compression bandaging, duration
Eligibility 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.
Sites / Locations
- Gloucestershire Royal Hospital NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
24 hours compression bandaging
5 days compression bandaging
Arm Description
Outcomes
Primary Outcome Measures
Change in Aberdeen Varicose Vein Score from time of treatment to 2 and 6 weeks after treatment
Secondary Outcome Measures
Change in Burford pain score from time of treatment to 2 and 6 weeks after treatment
Change in SF-36 score from time of treatment to 6 weeks after treatment.
Target vein occlusion rate on duplex imaging at 6 weeks
Number and type of complications seen
Full Information
NCT ID
NCT00991497
First Posted
October 7, 2009
Last Updated
October 7, 2009
Sponsor
Gloucestershire Hospitals NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT00991497
Brief Title
A Trial to Compare the Outcome of Localised Varicosity Compression for 24 Hours and 5 Days After Foam Sclerotherapy to Truncal Varices
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Gloucestershire Hospitals NHS Foundation Trust
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Veins
Keywords
varicose veins, foam sclerotherapy, compression bandaging, duration
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
24 hours compression bandaging
Arm Type
Active Comparator
Arm Title
5 days compression bandaging
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Compression bandaging
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Aberdeen Varicose Vein Score from time of treatment to 2 and 6 weeks after treatment
Time Frame
2 and 6 weeks
Secondary Outcome Measure Information:
Title
Change in Burford pain score from time of treatment to 2 and 6 weeks after treatment
Time Frame
2 and 6 weeks
Title
Change in SF-36 score from time of treatment to 6 weeks after treatment.
Time Frame
6 weeks
Title
Target vein occlusion rate on duplex imaging at 6 weeks
Time Frame
6 weeks
Title
Number and type of complications seen
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonothan J Earnshaw, FRCS, MD
Organizational Affiliation
Gloucestershire Royal Hospital NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gloucestershire Royal Hospital NHS Trust
City
Gloucester
State/Province
Gloucestershire
ZIP/Postal Code
GL1 3NN
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
20306530
Citation
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.
Results Reference
derived
Learn more about this trial
A Trial to Compare the Outcome of Localised Varicosity Compression for 24 Hours and 5 Days After Foam Sclerotherapy to Truncal Varices
We'll reach out to this number within 24 hrs