Varicose VeinsNCT00991497
A Trial to Compare the Outcome of Localised Varicosity Compression for 24 Hours and 5 Days After Foam Sclerotherapy to Truncal Varices
A study testing Compression bandaging in people with Varicose Veins, run by Gloucestershire Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Veins
- What is being tested?
- Compression bandaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2007to Jan 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Total deep venous reflux.
- Known allergy to liquid sclerosant.
- Pregnancy or breast feeding.
- Arterial disease.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Gloucestershire Royal Hospital NHS Trust
Gloucester, Gloucestershire, GL1 3NN
About this study
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
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.
- Conditions
- Varicose Veins
- Being tested
- Compression bandaging
- Keywords
- varicose veins, foam sclerotherapy, compression bandaging, duration
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression bandagingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 24 hours compression bandaging | Active comparator | Not described Receives: Device: Compression bandaging |
| 5 days compression bandaging | Active comparator | Not described Receives: Device: Compression bandaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Aberdeen Varicose Vein Score from time of treatment to 2 and 6 weeks after treatment
Measured: 2 and 6 weeks
Secondary outcomes (4)
Change in Burford pain score from time of treatment to 2 and 6 weeks after treatment
Measured: 2 and 6 weeks
Change in SF-36 score from time of treatment to 6 weeks after treatment.
Measured: 6 weeks
Target vein occlusion rate on duplex imaging at 6 weeks
Measured: 6 weeks
Number and type of complications seen
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2009 (estimated)
- Study startJan 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gloucestershire Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Investigators
- Jonothan J Earnshaw, FRCS, MD, Principal investigator, Gloucestershire Royal Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00991497
- Sponsor's protocol ID
- 06/Q2005/128
- Status last verified
- Oct 2009
- First submitted
- 7 Oct 2009
- Last updated
- 8 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20306530
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00991497
- Acronym / sponsor ID
- 06/Q2005/128
- Conditions
- Varicose Veins
- Keywords
- varicose veins, foam sclerotherapy, compression bandaging, duration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Gloucestershire Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 8 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 24 hours compression bandaging | Active comparator | Device: Compression bandaging |
| 5 days compression bandaging | Active comparator | Device: Compression bandaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Total deep venous reflux.
- Known allergy to liquid sclerosant.
- Pregnancy or breast feeding.
- Arterial disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compression bandagingCotton 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. | Device | 24 hours compression bandaging, 5 days compression bandaging |
Primary outcome
Change in Aberdeen Varicose Vein Score from time of treatment to 2 and 6 weeks after treatment
Time frame: 2 and 6 weeks
4 secondary outcomes
Change in Burford pain score from time of treatment to 2 and 6 weeks after treatment
Time frame: 2 and 6 weeks
Change in SF-36 score from time of treatment to 6 weeks after treatment.
Time frame: 6 weeks
Target vein occlusion rate on duplex imaging at 6 weeks
Time frame: 6 weeks
Number and type of complications seen
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2009.
- Derived from this study: PubMed 20306530O'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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonothan J Earnshaw, FRCS, MD principal investigator
Gloucestershire Royal Hospital NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compression bandaging in people with Varicose Veins, run by Gloucestershire Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00991497, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2009.