Varicose Veins Clinical Trial
Official title:
Efficacy of Vasculera in Prevention on Post-op Pain and Edema Following Lower Extremity Venous Treatment in the Outpatient Setting.
NCT number | NCT02936271 |
Other study ID # | 2016-137 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2016 |
Est. completion date | April 1, 2017 |
Verified date | November 2022 |
Source | Spectrum Health Hospitals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | April 1, 2017 |
Est. primary completion date | April 1, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Spectrum Health Hospitals | Grand Rapids | Michigan |
Lead Sponsor | Collaborator |
---|---|
Spectrum Health Hospitals | Primus Pharmaceuticals |
United States,
Bergan JJ. Chronic venous insufficiency and the therapeutic effects of Daflon 500 mg. Angiology. 2005 Sep-Oct;56 Suppl 1:S21-4. Review. — View Citation
Bogachev VIu, Golovanova OV, Kuzhetsov AN, Shekoian AO. [On advisability of perioperative phleboprotection in endovascular treatment of lower in varicose disease: first initial results of the decision study]. Angiol Sosud Khir. 2012;18(2):90-5. Russian. — View Citation
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Lyseng-Williamson KA, Perry CM. Micronised purified flavonoid fraction: a review of its use in chronic venous insufficiency, venous ulcers and haemorrhoids. Drugs. 2003;63(1):71-100. Review. — View Citation
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post-procedure Bruising | Physician and nurse examination | 2 weeks pre-procedure to 6 weeks post-procedure | |
Primary | Post-procedure Bleeding | Physician and nurse examination | 2 weeks pre-procedure to 6 weeks post-procedure | |
Primary | Post-procedure Pain | Pain scale | 2 weeks pre-procedure to 6 weeks post-procedure | |
Primary | Post-procedure Edema | Physician and nurse examination | 2 weeks pre-procedure to 6 weeks post-procedure | |
Secondary | Adverse Events | Adverse events per package insert. | 2 weeks pre-procedure to 6 weeks post-procedure | |
Secondary | Serious Adverse Events | Deep Vein Thrombosis (DVT) Pulmonary Embolism (PE) and Infection. | 2 weeks pre-procedure to 6 weeks post-procedure |
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