Efficacy of Vasculera in Prevention on Post-op Pain and Edema Following Lower Extremity Venous Treatment in the Outpatient Setting
Primary Purpose
Venous Insufficiency of Leg, Venous Reflux, Varicose Veins
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vasculera
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Venous Insufficiency of Leg focused on measuring Radiofrequency Ablation, Sclerotherapy, Vasculera
Eligibility Criteria
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
Sites / Locations
- Spectrum Health Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Active Vasculera (diosmiplex)
Vasculera Placebo
Arm Description
Active Vasculera will be prescribed as one (1) tablet (630 mg) twice a day.
Vasculera Placebo will be prescribed as one (1) tablet twice a day.
Outcomes
Primary Outcome Measures
Post-procedure Bruising
Physician and nurse examination
Post-procedure Bleeding
Physician and nurse examination
Post-procedure Pain
Pain scale
Post-procedure Edema
Physician and nurse examination
Secondary Outcome Measures
Adverse Events
Adverse events per package insert.
Serious Adverse Events
Deep Vein Thrombosis (DVT) Pulmonary Embolism (PE) and Infection.
Full Information
NCT ID
NCT02936271
First Posted
October 3, 2016
Last Updated
November 22, 2022
Sponsor
Spectrum Health Hospitals
Collaborators
Primus Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT02936271
Brief Title
Efficacy of Vasculera in Prevention on Post-op Pain and Edema Following Lower Extremity Venous Treatment in the Outpatient Setting
Official Title
Efficacy of Vasculera in Prevention on Post-op Pain and Edema Following Lower Extremity Venous Treatment in the Outpatient Setting.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Withdrawn
Study Start Date
October 2016 (undefined)
Primary Completion Date
April 1, 2017 (Actual)
Study Completion Date
April 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spectrum Health Hospitals
Collaborators
Primus Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
Lower extremity venous disease is thought to affect 50 percent of woman and 40 percent of men at some point in their lifetime. Many of these patients seek venous treatment and undergo surgical procedures in the outpatient setting. Patient undergoing surgical intervention for treatment of venous reflux disease often experience discomfort, edema and discoloration in the areas of treatment. These symptoms may affect them for weeks to months after the procedure.
Radiofrequency ablation (RFA) of greater saphenous, small saphenous or accessory saphenous vein follow by sclerotherapy of remaining tributary veins 1-2 weeks later is a common minimally invasive treatment. Both the RFA and the ultrasound guided sclerotherapy cause an inflammatory response which can make the post-operative period more difficult for patients then the procedure itself.
Vasculara has been shown to reduce inflammation, improve vascular tone and decrease tissue acidosis. It has also been shown to be effective in the treatment of post phlebitic syndrome and may reduce thrombotic complication. Recent animal data has demonstrated decreased postsclerotherapy inflammation in rabbits. In anecdotal reports providers have had good result with prescribing this medication to patients to be take a week or two prior to the procedure and in the post-op period, however, evidence for this practice is lacking. Vasculara is a generally safe product with very limited side effects and thus could be applied to a large patient population if clear benefit were documented.
Vasculera is a prescription medical food product composed of the flavonoid, diosmin and a proprietary systemic blood alkalinizing agent, Alka4-complex. Diosmin has been used successfully in Europe for more than 35 years in the treatment of chronic venous insufficiency and its complications. There is a large body of published literature regarding the molecular activity, clinical efficacy and safety of diosmin as well as its effects on the microvasculature where it has been shown to reduce inflammation, improve structural integrity, improve capillary flow and reduce capillary leakage of serum proteins and red blood cells. It decreases bradykinin-induced microvascular leakage and may act favorably to inhibit leukocyte activation, trapping, and migration. Clinically, edema is reduced, ulcer healing is accelerated, and leukocyte trapping diminished.
A similar study with similar design to this study from a Russian group demonstrated the "feasibility of using the drug Detralex, a brand of diosmin marketed in Europe, as an agent for nonspecific pharmacological protection in endovascular treatment of varicose disease." In 2007 the DEFANS trial, also from Russia concluded, micronized diosmin in pre- and postoperative period after phlebectomy helps to attenuate pain syndrome, to decrease postoperative hematomas and accelerate their resorption, to increase exercise tolerance in early postoperative period. Studies performed within the United States with modern surgical procedures are lacking.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Insufficiency of Leg, Venous Reflux, Varicose Veins, Lower Extremity Edema Chronic
Keywords
Radiofrequency Ablation, Sclerotherapy, Vasculera
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Vasculera (diosmiplex)
Arm Type
Active Comparator
Arm Description
Active Vasculera will be prescribed as one (1) tablet (630 mg) twice a day.
Arm Title
Vasculera Placebo
Arm Type
Placebo Comparator
Arm Description
Vasculera Placebo will be prescribed as one (1) tablet twice a day.
Intervention Type
Other
Intervention Name(s)
Vasculera
Other Intervention Name(s)
Diosmiplex, Prescription medical food product
Intervention Description
Vasculera is a specially formulated prescription medical food product. This study compares Vasculera to placebo at reducing post procedural pain, bruising and edema for patients requiring an intervention for lower extremity venous disease.
Patient will be randomized to receive Active Vasculera or Vasculera Placebo. The study product will be taken for two weeks prior to the patient's planned procedure and continued for four weeks after their procedure. If multiple procedures are required the patient will be instructed to use the product throughout treatment.
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Post-procedure Bruising
Description
Physician and nurse examination
Time Frame
2 weeks pre-procedure to 6 weeks post-procedure
Title
Post-procedure Bleeding
Description
Physician and nurse examination
Time Frame
2 weeks pre-procedure to 6 weeks post-procedure
Title
Post-procedure Pain
Description
Pain scale
Time Frame
2 weeks pre-procedure to 6 weeks post-procedure
Title
Post-procedure Edema
Description
Physician and nurse examination
Time Frame
2 weeks pre-procedure to 6 weeks post-procedure
Secondary Outcome Measure Information:
Title
Adverse Events
Description
Adverse events per package insert.
Time Frame
2 weeks pre-procedure to 6 weeks post-procedure
Title
Serious Adverse Events
Description
Deep Vein Thrombosis (DVT) Pulmonary Embolism (PE) and Infection.
Time Frame
2 weeks pre-procedure to 6 weeks post-procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer J. Watson, MD
Organizational Affiliation
Spectrum Health Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spectrum Health Hospitals
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
3395496
Citation
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Citation
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19648874
Citation
Zahariev T, Anastassov V, Girov K, Goranova E, Grozdinski L, Kniajev V, Stankev M. Prevalence of primary chronic venous disease: the Bulgarian experience. Int Angiol. 2009 Aug;28(4):303-10.
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PubMed Identifier
16193222
Citation
Bergan JJ. Chronic venous insufficiency and the therapeutic effects of Daflon 500 mg. Angiology. 2005 Sep-Oct;56 Suppl 1:S21-4. doi: 10.1177/00033197050560i104.
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8798349
Citation
Tsimoyiannis EC, Floras G, Antoniou N, Papanikolaou N, Siakas P, Tassis A. Low-molecular-weight heparins and Daflon for prevention of postoperative thromboembolism. World J Surg. 1996 Oct;20(8):968-71; discussion 972. doi: 10.1007/s002689900145.
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Citation
de Souza Md, Cyrino FZ, Mayall MR, Virgini-Magalhaes CE, Sicuro FL, de Carvalho JJ, Verbeuren TJ, Bouskela E. Beneficial effects of the micronized purified flavonoid fraction (MPFF, Daflon(R) 500 mg) on microvascular damage elicited by sclerotherapy. Phlebology. 2016 Feb;31(1):50-6. doi: 10.1177/0268355514564414. Epub 2014 Dec 15.
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Citation
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Citation
Ramelet AA. Clinical benefits of Daflon 500 mg in the most severe stages of chronic venous insufficiency. Angiology. 2001 Aug;52 Suppl 1:S49-56. doi: 10.1177/0003319701052001S07.
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Citation
Shoab SS, Scurr JH, Coleridge-Smith PD. Plasma VEGF as a marker of therapy in patients with chronic venous disease treated with oral micronised flavonoid fraction - a pilot study. Eur J Vasc Endovasc Surg. 1999 Oct;18(4):334-8. doi: 10.1053/ejvs.1999.0890.
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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.
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Links:
URL
http://www.vasculera.com/
Description
Product website
Learn more about this trial
Efficacy of Vasculera in Prevention on Post-op Pain and Edema Following Lower Extremity Venous Treatment in the Outpatient Setting
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