Efficacy of Vasculera in Prevention on Post-op Pain and Edema Following Lower Extremity Venous Tr… (NCT02936271) | Clinical Trial Compass
WithdrawnNot Applicable
Efficacy of Vasculera in Prevention on Post-op Pain and Edema Following Lower Extremity Venous Treatment in the Outpatient Setting
United States0Started 2016-10
Plain-language summary
The purpose of this study is to evaluate the effectiveness of Vasculera in reducing post procedural pain, bruising and edema in the post procedure period for patients diagnosed with C2-C5 disease requiring an intervention(s).
The hypothesis is that Vasculera will reduce post procedural pain, bruising and edema for patients requiring an intervention.
This will be a randomized, double-blind, placebo-controlled study. Vasculera is a specially formulated prescription medical food product for the clinical dietary management of the metabolic processes of chronic venous insufficiency. Vasculera has limited side effects, please see the product insert.
A total of 110 patients will be enrolled into this study. Patients will be randomized to receive Vasculera (Study Product) or placebo. Study Product or placebo will be prescribed as one (1) tablet twice a day.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients 18 years of age or older with C2-C5 disease undergoing radiofrequency ablation; foam and/or sclerotherapy
* Women of childbearing age must be using birth control to be candidates for study participation
Exclusion Criteria:
* Pregnant or nursing women
* Patients that are 85 years of age or older
* Patients who are unable to provide consent
* Prisoners or vulnerable population, including non-English speaking patients
* C1 Disease
* Patient on Chlorzoxazone, Diclofenac, Metronidazole
* Use of recreational drugs including alcohol in excess of 1 unit daily (for purposes of this study, a unit of alcohol is defined as 6 oz of wine, 12 oz of beer or 2 oz of hard spirits)
* Participation in another clinical trial within 7 half-lives of the prior study agent prior to the screening visit
* More than three planned surgical intervention procedures
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Post-procedure Bruising
Timeframe: 2 weeks pre-procedure to 6 weeks post-procedure
2
Post-procedure Bleeding
Timeframe: 2 weeks pre-procedure to 6 weeks post-procedure
3
Post-procedure Pain
Timeframe: 2 weeks pre-procedure to 6 weeks post-procedure
4
Post-procedure Edema
Timeframe: 2 weeks pre-procedure to 6 weeks post-procedure