RCT of compression therapy following foam sclerotherapy
Research type
Research Study
Full title
A randomised controlled trial of compression therapy following foam sclerotherapy of varicose veins
IRAS ID
187992
Contact name
Alun H Davies
Contact email
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
Summary of Research
This study will be looking at the effect of compression therapy in patients receiving endovenous treatment for varicose veins using foam sclerotherapy.Despite the International Union of Phlebology (UIP) recommending the use of compression for certain indications, there remains uncertainty about the use of compression stockings following treatment of varicose veins (Partsch and Baccaglini, 1995). Thus, the NICE guidelines (UK) (2013) on varicose veins recommend further research to evaluate the clinical and cost-effectiveness of this post-procedure intervention (NICE, 2013).
Hamel-Desnos et al. previously undertook a randomised controlled trial looking at the effect of compression in patients receiving foam sclerotherapy of the saphenous vein (Hamel-Desnos et al., 2010). They noted that patients with compression had similar pain and quality of life scores to patients not wearing any compression. Sixty patients were recruited in the trial and it could be hypothesised that the population was not large enough to demonstrate a difference.
Therefore, we plan to undertake another randomised controlled trial looking at the effect of compression therapy after endovenous treatment using foam. Patients will be randomised to either a compression group (group A) or a no compression group (group B).
Based on our power calculations, we estimate we will need to recruit and randomise 350 patients.
Our inclusion criteria include adults with varicose veins suitable for foam sclerotherapy. We would exclude patients with current deep vein thrombosis or peripheral arterial disease.
The primary objective of the study will be patient’s pain score for the first 10 days post-procedure using a validated visual analogue scale (VAS). Secondary objectives will be to compare the two treatment groups with respect to quality of life scores, clinical scores, degree of phlebitis, time to return to normal activities and occlusion rate at 6 months.
This study is expected to recruit over a period of 12 months, with patients followed up for 6 months.
Summary of Results
Clinical Trial identification
1.1 Study name:
Randomised controlled trial of compression following foam sclerotherapy for varicose veins
1.2 Protocol number: N/A
1.3 Identifiers:
The trial was registered at ClinicalTrials.gov (NCT02655406) and ISRCTNregistry (ISRCTN17719156)
1.4 ABSTRACT:
Purpose of study: The purpose of this study was to compare the effect of compression therapy following foam sclerotherapy for varicose veins.
What was tested: Patients were randomised to either the compression stockings group (group A) or the no compression stockings group (group B).
Patients taking part: 139 patients with mean age 57.7 years who had varicose veins took part in this study.
Results: This study found that pain score was less in the compression stockings group (group A) when compared to the no compression stockings group (group B).
2. Name and contact of sponsor
2. Who sponsored this study
This study was sponsored by Imperial College London (Joint Research Compliance Office Reference number: 15HH2894).
3. General information about the clinical trial
3.1 Where was the study done?
This study took place at the Imperial College Healthcare NHS Trust, London, United Kingdom.
3.2 When was this done?
This trial started in January 2016 and ended in January 2019.
3.3 What was the main objective of this study?
The main objective of this study was to look at the effect of compression therapy in patients having varicose veins treatment using foam sclerotherapy. Patients suitable for foam sclerotherapy were consented and randomly assigned to receive either compression stockings or no compression stockings using an online randomization service (Sealed EnvelopeTM) 4. Population of subjects
4.1 What patient/ people were included in this study?
Patients with varicose vein were randomised to one of two groups.
4.2 The number of subjects included in the trail
139 symptomatic patients with varicose veins were randomised into either group A (70 patient) or group B (69 patients).4.3 Age group and gender breakdown
54 of the patients were women in group A and 47 in group B, with mean age in group A was 57 years and 58 years in group B.
4.4 Inclusion and exclusion criteria
Inclusion Criteria
• Adults over 18 years of age and having varicose veins suitable for foam sclerotherapy.
Exclusion Criteria
• Current DVT
• Allergy to sclerosant
• Arterial disease (ABPI<0.8)
• Patient who are unwilling to participate
• Inability or unwillingness to complete questionnaires
• Inability to attend follow-up appointments5. Which medicines were studied?
Compression Stockings
6. What were the side effects?
None
7. What were the overall results of the study?
The findings of this study showed that pain score was less in the compression stockings group (group A) when compared to the no compression stockings group (group B). Follow-up data demonstrated that there was no difference between the groups regarding the clinical, quality of life scores, time return to normal activities or work, ecchymosis score and occlusion rates.
8. How has this study helped patients and researcher?
Finding from this study will be used to inform the researcher and patients that wearing compression stockings for 7 days following foam sclerotherapy leads to a reduction in pain score postoperatively with no difference in terms of clinical, quality of life and occlusion rates. This study suggests that wearing compression stockings for a short time in the post-operative period is beneficial, however, no longer term advantages could be demonstrated.
9. Where can I find more information about this study?
To learn more about this study, you can find more detailed information on this website At the ClinicalTrials.gov (NCT02655406) and ISRCTNregistry (ISRCTN17719156)REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
15/NE/0314
Date of REC Opinion
9 Sep 2015
REC opinion
Favourable Opinion