Efficacy of Vasculera in Prevention on Post-op Pain and Edema Following Lower Extremity Venous Treatment in the Outpatient Setting

Withdrawn before enrolling · Not applicable · Has a placebo group

Conditions studied: Venous Insufficiency of Leg, Venous Reflux, Varicose Veins, Lower Extremity Edema Chronic

In brief

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.

Key facts

Study ID

NCT02936271

Run by

Corewell Health West

People needed

0

Starts

2016-10-01

Expected to finish

2017-04-01

Last updated by the study team

2022-11-23

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Spectrum Health Hospitals — Grand Rapids, Michigan, United States

Full record on ClinicalTrials.gov

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