Varicose VeinsCOMMOCANCT03685838
Compression Stockings Therapy Following Mechano-Chemical Ablation (Clarivein®)
A study testing Compression Stockings in people with Varicose Veins and Chronic Venous Insufficiency, run by Singapore General Hospital at 2 sites in 2 countries.
Trial summary
This study will be looking at the effect of compression therapy in patients having Mechano-Chemical Ablation (MOCA) therapy for truncal incompetence of their varicose veins using the ClariVein® device. Patients will be randomised to either the compression group (group A) or the no compression group (group B). Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Varicose Veins, Chronic Venous Insufficiency
- What is being tested?
- Compression Stockings
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 13 Feb 2019to 1 Oct 2022
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>=21 to <=80
- Able to walk unassisted and attend follow-up visits
- Symptomatic Great Saphenous Vein (GSV) or Small Saphenous Vein (SSV) vein reflux >0.5 seconds on colour Duplex ultrasound
- Able to provide informed consent
Who cannot join
- Previous or current deep vein thrombosis or pulmonary embolism
- Patients with a hypercoaguable state
- Previous thrombophlebitis in the truncal vein in question, which had recanalized and was now incompetent on duplex ultrasound
- Recurrent varicose vein i.e. patients who have had treatment previously in the designated truncal vein with any modality
- Patients who have had treatment in either leg for an incompetent saphenous truncal vein less than 3 months prior to treatment and enrolment into this study
- Patients requiring adjuvant treatment of varicose veins
Show all 17Show fewer
- Arterial disease (ABPI < 0.6 and the absence of a palpable pedal pulse)
- Vein diameter <3mm or >12mm as measured in the standing position on duplex ultrasound
- Varicose veins unsuitable for MOCA (e.g. very tortuous vein)
- Pregnancy
- Lycra, sclerosant or local anaesthetic allergy
- Patients who have opted for an alternative method of treatment
- Patients with fibromyalgia
- Patients with Clinical, Etiologic, Anatomic and Pathophysiologic (CEAP) score of C6 (active ulcer), C1 and C2 (asymptomatic) disease
- Patients with a life expectancy less than 12 months
- Inability or unwillingness to complete questionnaires
- Patients who refuses to participate and unable to provide informed consent or comply with the study protocol.
Trial locations and contacts
2 sites in 2 countries.
Charyl Yap contact
2 sites in 2 countries
Ireland1 site, 1 recruiting
- Recruiting
Galway University Hospital
Galway, Galway
Prof Stewart Walsh
Singapore1 site, 1 recruiting
- Recruiting
Singapore General Hospital
Singapore
About this study
Official title: A Randomised Controlled Trial of Compression Stockings Therapy Following Mechano-Chemical Ablation
This study will be looking at the effect of compression therapy in patients having Mechano-Chemical Ablation (MOCA) therapy for truncal incompetence of their varicose veins using the ClariVein® device. Patients will be randomised to either the compression group (group A) or the no compression group (group B).
The pain scores, compliance, quality of life scores, occlusion rate at 6 months as well as the cost effectiveness of each intervention will be assessed.
Read the detailed description
Varicose veins are common and are known to affect approximately one third of the population. Chronic Venous Disease (CVD) has been shown to have a negative impact on the quality of life of patients and treatment of varicose veins has been demonstrated to lead to improvement in the quality of life of patients. Over the past decade, new endovenous techniques have been introduced and these are felt to be cost-effective, especially, when performed in an outpatient or 'office-based' setting.
There is currently uncertainty about the use of compression stockings following treatment of varicose veins. International Union of Phlebology (IUP), The Society for Vascular Surgery and the American Venous Forum, as well as 2013 National Institute for Health and Care Excellence (NICE) Guideline on Varicose Veins in the Legs have recommended that compression stockings are suitable in certain clinical indications and can be worn post-operatively for no more than 7 days after interventional treatment to prevent haematoma formation, pain and swelling. However, further research is essential for determining clinical and cost effectiveness, as well as length of time compression should be worn, and level of compression.
Several researchers have looked into the practice of using compression after venous ablation. In a survey of the management of varicose veins by the members of the Vascular Society of Great Britain and Ireland. Edwards et al. found that the majority of surgeons used bandages post-operatively, with 49% using elastic bandage. To date, the literature on the use of compression stockings following treatment of varicose veins is limited.
Mechano-Chemical Ablation (MOCA) combines mechanical damage to the endothelium caused by a rotating wire with simultaneous catheter-guided infusion of a liquid sclerosant that irreversibly damages the cellular membrane of the endothelium, causing fibrosis of the vein. The exact mechanism is still not exactly known. However, recent experimental research showed that various sclerosants induced apoptosis in the vein wall rather than having an effect restricted to the endothelium. Incomplete loss of endothelial cells and penetration of the sclerosant effect into the media suggest that medial damage is crucial to the success of sclerotherapy and may explain why it is less effective in larger veins. This poses the question whether compression is needed post sclerotherapy to improve contact of the sclerosant to the endothelium when media penetration seems to be more important to allow apoptosis of smooth muscle cells.
The investigators therefore propose to undertake a randomised study looking at the effect of compression therapy after MOCA using Clarivein device
- Conditions
- Varicose Veins, Chronic Venous Insufficiency
- Being tested
- Compression Stockings
- Keywords
- mechano-chemical ablation, compression stockings
- 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 StockingsOther
Class II above knee compression stockings
| Study group | Role | What they receive |
|---|---|---|
| Compression | Active comparator | Patient will receive Class II above knee compression stockings, and will be asked to wear it for 1 week. This would involve wearing the stocking during daytime but patients will be allowed to take it off at night whilst in bed. Receives: Other: Compression Stockings |
| No Compression | No intervention | Patient will not receive any compression stockings. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score post-procedure
Participants will record their pain score using the Visual Analogue Score (VAS) for pain. The scale ranges from 0 (no pain) to 10 (worst pain imaginable).
Measured: First 10 days post-procedure
Secondary outcomes (10)
Quality of Life score using the EQ-5D questionnaire
EQ-5D is used to assess quality of life based on Mobility, Self-care, Usual Activities, Pain/Discomfort and Anxiety, rated at 5 levels: no problems, slight problems, moderate problems, severe problems, unable to perform activity. Inputs from this questionnaire is used to observe for changes in quality of life overtime
Measured: Baseline, 2 weeks post-op, 6 months post-op
Quality of life score using the Chronic Venous Insufficiency Questionnaire (CIVIQ)
CIVIQ-14 is a questionnaire based on three dimensions - pain, physical and psychological, based on a scale from 1 to 5 (no trouble, slight, moderate, considerable, severe). Based on inputs, Global Index Score (GIS) will be tabulated, ranging from 0 to 100 - the higher the value, the poorer the quality of life.
Measured: Baseline, 2 weeks post-op, 6 months post-op
Quality of life score using the Aberdeen Varicose Veins Questionnaire (AVVQ)
To measure health status of varicose vein patients based on symptoms and impact on daily activities. A total score ranging from 0 to 100 will be tabulated, with 100 being worst quality of life
Measured: Baseline, 2 weeks post-op, 6 months post-op
Clinical Change using Venous Clinical Severity Score (VCSS)
VCSS evaluates the severity of hallmarks of venous disease - 0 (none), 1 (Mild) , 2(Moderate), 3 (Severe).
Measured: Baseline, 2 weeks post-op, 6 months post-op
Time taken to return to work and normal activities
Measured: 10 days post-op
Degree of bruising and phlebitis
Assessed using a pre-determined score (0=0%; 1= <25% of treated vein affected; 2 = 25-50% ; 3 = 50-75%; 4 = 75-100% and 5 = extending beyond the treated vein
Measured: 2 weeks post-op, 6 months post-op
The number of patient compliant with the intervention
Measured: 10 days post-op
Patient's satisfaction
To rate satisfaction with overall teatment regime with a numerical scale of 0 (least satisfied) to 10 (most satisfied)
Measured: 2 weeks post-op, 6 months post-op
Comparison of the cost-effectiveness of the intervention
Analyze cost and patient outcomes to determine effectiveness of interventions
Measured: 6 months post-op
Successful obliteration of target vein
This is assessed by duplex ultrasound scan. Recanalization will be defined by a segment of vein greater than or equal to 5cm
Measured: 2 weeks post-op, 6 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start13 Feb 2019
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Ireland, Galway, Ireland
- Responsible party
- Sponsor
- Investigators
- Tang Tjun Yip, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03685838
- Sponsor's protocol ID
- COMMOCA
- Acronym
- COMMOCA
- Status last verified
- Oct 2020
- First submitted
- 21 Sep 2018
- Last updated
- 30 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Evans CJ, Fowkes FG, Ruckley CV, Lee AJ. Prevalence of varicose veins and chronic venous insufficiency in men and women in the general population: Edinburgh Vein Study. J Epidemiol Community Health. 1999 Mar;53(3):149-53. doi: 10.1136/jech.53.3.149.
PubMed 10396491Sakurai H, Naito H. A cross-resistance of Pyricularia oryzae Cavara to kasugamycin and blasticidin S. J Antibiot (Tokyo). 1976 Dec;29(12):1341-2. doi: 10.7164/antibiotics.29.1341. No abstract available.
PubMed 1051420Biemans AA, Kockaert M, Akkersdijk GP, van den Bos RR, de Maeseneer MG, Cuypers P, Stijnen T, Neumann MH, Nijsten T. Comparing endovenous laser ablation, foam sclerotherapy, and conventional surgery for great saphenous varicose veins. J Vasc Surg. 2013 Sep;58(3):727-34.e1. doi: 10.1016/j.jvs.2012.12.074. Epub 2013 Jun 13.
PubMed 23769603MacKenzie RK, Paisley A, Allan PL, Lee AJ, Ruckley CV, Bradbury AW. The effect of long saphenous vein stripping on quality of life. J Vasc Surg. 2002 Jun;35(6):1197-203. doi: 10.1067/mva.2002.121985.
PubMed 12042731van den Bos R, Arends L, Kockaert M, Neumann M, Nijsten T. Endovenous therapies of lower extremity varicosities: a meta-analysis. J Vasc Surg. 2009 Jan;49(1):230-9. doi: 10.1016/j.jvs.2008.06.030. Epub 2008 Aug 9.
PubMed 18692348Gloviczki P, Comerota AJ, Dalsing MC, Eklof BG, Gillespie DL, Gloviczki ML, Lohr JM, McLafferty RB, Meissner MH, Murad MH, Padberg FT, Pappas PJ, Passman MA, Raffetto JD, Vasquez MA, Wakefield TW; Society for Vascular Surgery; American Venous Forum. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg. 2011 May;53(5 Suppl):2S-48S. doi: 10.1016/j.jvs.2011.01.079.
PubMed 21536172Marsden G, Perry M, Kelley K, Davies AH; Guideline Development Group. Diagnosis and management of varicose veins in the legs: summary of NICE guidance. BMJ. 2013 Jul 24;347:f4279. doi: 10.1136/bmj.f4279. No abstract available.
PubMed 23884969Edwards AG, Baynham S, Lees T, Mitchell DC. Management of varicose veins: a survey of current practice by members of the Vascular Society of Great Britain and Ireland. Ann R Coll Surg Engl. 2009 Jan;91(1):77-80. doi: 10.1308/003588409X358953. Epub 2008 Nov 4.
PubMed 18990266Fonken LK, Weil ZM, Nelson RJ. Mice exposed to dim light at night exaggerate inflammatory responses to lipopolysaccharide. Brain Behav Immun. 2013 Nov;34:159-63. doi: 10.1016/j.bbi.2013.08.011. Epub 2013 Sep 6.
PubMed 24012645Elderman JH, Krasznai AG, Voogd AC, Hulsewe KW, Sikkink CJ. Role of compression stockings after endovenous laser therapy for primary varicosis. J Vasc Surg Venous Lymphat Disord. 2014 Jul;2(3):289-96. doi: 10.1016/j.jvsv.2014.01.003. Epub 2014 Feb 14.
PubMed 26993388Hamel-Desnos CM, Guias BJ, Desnos PR, Mesgard A. Foam sclerotherapy of the saphenous veins: randomised controlled trial with or without compression. Eur J Vasc Endovasc Surg. 2010 Apr;39(4):500-7. doi: 10.1016/j.ejvs.2009.11.027. Epub 2010 Jan 25.
PubMed 20097585Whiteley MS, Dos Santos SJ, Fernandez-Hart TJ, Lee CT, Li JM. Media Damage Following Detergent Sclerotherapy Appears to be Secondary to the Induction of Inflammation and Apoptosis: An Immunohistochemical Study Elucidating Previous Histological Observations. Eur J Vasc Endovasc Surg. 2016 Mar;51(3):421-8. doi: 10.1016/j.ejvs.2015.11.011. Epub 2016 Jan 17.
PubMed 26790396Joyce DP, Walsh SR, Yap CJQ, Chong TT, Tang TY. Compression therapy following ClariVein(R) ablation therapy: a randomised controlled trial of COMpression Therapy Following MechanO-Chemical Ablation (COMMOCA). Trials. 2019 Dec 5;20(1):678. doi: 10.1186/s13063-019-3787-4.
PubMed 31806052
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Compression Stockings Therapy Following Mechano-Chemical Ablation
- ClinicalTrials.gov ID
- NCT03685838
- Acronym / sponsor ID
- COMMOCA / COMMOCA
- Conditions
- Varicose Veins, Chronic Venous Insufficiency
- Keywords
- mechano-chemical ablation, compression stockings
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- National University of Ireland, Galway, Ireland
- Study start
- 13 Feb 2019 (actual)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 26 Sep 2018 (actual)
- 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.
This study will be looking at the effect of compression therapy in patients having Mechano-Chemical Ablation (MOCA) therapy for truncal incompetence of their varicose veins using the ClariVein® device. Patients will be randomised to either the compression group (group A) or the no compression group (group B).
The pain scores, compliance, quality of life scores, occlusion rate at 6 months as well as the cost effectiveness of each intervention will be assessed.
Detailed description
Varicose veins are common and are known to affect approximately one third of the population. Chronic Venous Disease (CVD) has been shown to have a negative impact on the quality of life of patients and treatment of varicose veins has been demonstrated to lead to improvement in the quality of life of patients. Over the past decade, new endovenous techniques have been introduced and these are felt to be cost-effective, especially, when performed in an outpatient or 'office-based' setting.
There is currently uncertainty about the use of compression stockings following treatment of varicose veins. International Union of Phlebology (IUP), The Society for Vascular Surgery and the American Venous Forum, as well as 2013 National Institute for Health and Care Excellence (NICE) Guideline on Varicose Veins in the Legs have recommended that compression stockings are suitable in certain clinical indications and can be worn post-operatively for no more than 7 days after interventional treatment to prevent haematoma formation, pain and swelling. However, further research is essential for determining clinical and cost effectiveness, as well as length of time compression should be worn, and level of compression.
Several researchers have looked into the practice of using compression after venous ablation. In a survey of the management of varicose veins by the members of the Vascular Society of Great Britain and Ireland. Edwards et al. found that the majority of surgeons used bandages post-operatively, with 49% using elastic bandage. To date, the literature on the use of compression stockings following treatment of varicose veins is limited.
Mechano-Chemical Ablation (MOCA) combines mechanical damage to the endothelium caused by a rotating wire with simultaneous catheter-guided infusion of a liquid sclerosant that irreversibly damages the cellular membrane of the endothelium, causing fibrosis of the vein. The exact mechanism is still not exactly known. However, recent experimental research showed that various sclerosants induced apoptosis in the vein wall rather than having an effect restricted to the endothelium. Incomplete loss of endothelial cells and penetration of the sclerosant effect into the media suggest that medial damage is crucial to the success of sclerotherapy and may explain why it is less effective in larger veins. This poses the question whether compression is needed post sclerotherapy to improve contact of the sclerosant to the endothelium when media penetration seems to be more important to allow apoptosis of smooth muscle cells.
The investigators therefore propose to undertake a randomised study looking at the effect of compression therapy after MOCA using Clarivein device
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compression | Active comparator | Other: Compression StockingsPatient will receive Class II above knee compression stockings, and will be asked to wear it for 1 week. This would involve wearing the stocking during daytime but patients will be allowed to take it off at night whilst in bed. |
| No Compression | No intervention | –Patient will not receive any compression stockings. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age>=21 to <=80
- Able to walk unassisted and attend follow-up visits
- Symptomatic Great Saphenous Vein (GSV) or Small Saphenous Vein (SSV) vein reflux >0.5 seconds on colour Duplex ultrasound
- Able to provide informed consent
Key exclusion criteria (17 listed)
- Previous or current deep vein thrombosis or pulmonary embolism
- Patients with a hypercoaguable state
- Previous thrombophlebitis in the truncal vein in question, which had recanalized and was now incompetent on duplex ultrasound
- Recurrent varicose vein i.e. patients who have had treatment previously in the designated truncal vein with any modality
- Patients who have had treatment in either leg for an incompetent saphenous truncal vein less than 3 months prior to treatment and enrolment into this study
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 StockingsClass II above knee compression stockings | Other | Compression |
Primary outcome
Pain Score post-procedure
Time frame: First 10 days post-procedure
Participants will record their pain score using the Visual Analogue Score (VAS) for pain. The scale ranges from 0 (no pain) to 10 (worst pain imaginable).
10 secondary outcomes
Quality of Life score using the EQ-5D questionnaire
Time frame: Baseline, 2 weeks post-op, 6 months post-op
Quality of life score using the Chronic Venous Insufficiency Questionnaire (CIVIQ)
Time frame: Baseline, 2 weeks post-op, 6 months post-op
Quality of life score using the Aberdeen Varicose Veins Questionnaire (AVVQ)
Time frame: Baseline, 2 weeks post-op, 6 months post-op
Clinical Change using Venous Clinical Severity Score (VCSS)
Time frame: Baseline, 2 weeks post-op, 6 months post-op
Time taken to return to work and normal activities
Time frame: 10 days post-op
Degree of bruising and phlebitis
Time frame: 2 weeks post-op, 6 months post-op
The number of patient compliant with the intervention
Time frame: 10 days post-op
Patient's satisfaction
Time frame: 2 weeks post-op, 6 months post-op
Comparison of the cost-effectiveness of the intervention
Time frame: 6 months post-op
Successful obliteration of target vein
Time frame: 2 weeks post-op, 6 months post-op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
- Background: PubMed 10396491Evans CJ, Fowkes FG, Ruckley CV, Lee AJ. Prevalence of varicose veins and chronic venous insufficiency in men and women in the general population: Edinburgh Vein Study. J Epidemiol Community Health. 1999 Mar;53(3):149-53. doi: 10.1136/jech.53.3.149.
- Background: PubMed 1051420Sakurai H, Naito H. A cross-resistance of Pyricularia oryzae Cavara to kasugamycin and blasticidin S. J Antibiot (Tokyo). 1976 Dec;29(12):1341-2. doi: 10.7164/antibiotics.29.1341. No abstract available.
- Background: PubMed 23769603Biemans AA, Kockaert M, Akkersdijk GP, van den Bos RR, de Maeseneer MG, Cuypers P, Stijnen T, Neumann MH, Nijsten T. Comparing endovenous laser ablation, foam sclerotherapy, and conventional surgery for great saphenous varicose veins. J Vasc Surg. 2013 Sep;58(3):727-34.e1. doi: 10.1016/j.jvs.2012.12.074. Epub 2013 Jun 13.
- Background: PubMed 12042731MacKenzie RK, Paisley A, Allan PL, Lee AJ, Ruckley CV, Bradbury AW. The effect of long saphenous vein stripping on quality of life. J Vasc Surg. 2002 Jun;35(6):1197-203. doi: 10.1067/mva.2002.121985.
- Background: PubMed 18692348van den Bos R, Arends L, Kockaert M, Neumann M, Nijsten T. Endovenous therapies of lower extremity varicosities: a meta-analysis. J Vasc Surg. 2009 Jan;49(1):230-9. doi: 10.1016/j.jvs.2008.06.030. Epub 2008 Aug 9.
- Background: PubMed 21536172Gloviczki P, Comerota AJ, Dalsing MC, Eklof BG, Gillespie DL, Gloviczki ML, Lohr JM, McLafferty RB, Meissner MH, Murad MH, Padberg FT, Pappas PJ, Passman MA, Raffetto JD, Vasquez MA, Wakefield TW; Society for Vascular Surgery; American Venous Forum. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg. 2011 May;53(5 Suppl):2S-48S. doi: 10.1016/j.jvs.2011.01.079.
- Background: PubMed 23884969Marsden G, Perry M, Kelley K, Davies AH; Guideline Development Group. Diagnosis and management of varicose veins in the legs: summary of NICE guidance. BMJ. 2013 Jul 24;347:f4279. doi: 10.1136/bmj.f4279. No abstract available.
- Background: PubMed 18990266Edwards AG, Baynham S, Lees T, Mitchell DC. Management of varicose veins: a survey of current practice by members of the Vascular Society of Great Britain and Ireland. Ann R Coll Surg Engl. 2009 Jan;91(1):77-80. doi: 10.1308/003588409X358953. Epub 2008 Nov 4.
- Background: PubMed 24012645Fonken LK, Weil ZM, Nelson RJ. Mice exposed to dim light at night exaggerate inflammatory responses to lipopolysaccharide. Brain Behav Immun. 2013 Nov;34:159-63. doi: 10.1016/j.bbi.2013.08.011. Epub 2013 Sep 6.
- Background: PubMed 26993388Elderman JH, Krasznai AG, Voogd AC, Hulsewe KW, Sikkink CJ. Role of compression stockings after endovenous laser therapy for primary varicosis. J Vasc Surg Venous Lymphat Disord. 2014 Jul;2(3):289-96. doi: 10.1016/j.jvsv.2014.01.003. Epub 2014 Feb 14.
- Background: PubMed 20097585Hamel-Desnos CM, Guias BJ, Desnos PR, Mesgard A. Foam sclerotherapy of the saphenous veins: randomised controlled trial with or without compression. Eur J Vasc Endovasc Surg. 2010 Apr;39(4):500-7. doi: 10.1016/j.ejvs.2009.11.027. Epub 2010 Jan 25.
- Background: PubMed 26790396Whiteley MS, Dos Santos SJ, Fernandez-Hart TJ, Lee CT, Li JM. Media Damage Following Detergent Sclerotherapy Appears to be Secondary to the Induction of Inflammation and Apoptosis: An Immunohistochemical Study Elucidating Previous Histological Observations. Eur J Vasc Endovasc Surg. 2016 Mar;51(3):421-8. doi: 10.1016/j.ejvs.2015.11.011. Epub 2016 Jan 17.
- Individual participant dataSharing planned: No
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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.
Charyl Yap contact
Tang Tjun Yip principal investigator
Singapore General Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compression Stockings in people with Varicose Veins and Chronic Venous Insufficiency, run by Singapore General Hospital at 2 sites in 2 countries.
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 4 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 30 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ireland, Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tang Tjun Yip (65767986, tang.tjun.yip@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score post-procedure (time frame: First 10 days post-procedure). 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 NCT03685838, which also lists 13 linked publications.
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 30 Oct 2020.