Efficacy of Vasculera in Prevention on Post-op Pain and Edema Following Lower Extremity Venous Treatment in the Outpatient Setting
WithdrawnNot applicableNCT02936271
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Efficacy of Vasculera in Prevention on Post-op Pain and Edema Following Lower Extremity Venous Treatment in the Outpatient Setting.
- Conditions
- Venous Insufficiency of Leg
- Venous Reflux
- Varicose Veins
- Lower Extremity Edema Chronic
- Interventions
- Other: Vasculera
- Other: Placebo
- Sponsor
- Corewell Health West
- Collaborators
- Primus Pharmaceuticals
- Start date
- 2016-10
- Primary completion
- 2017-04-01
- Sex
- All
- Age range
- from 18 Years to 85 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02936271