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

NCT02936271 | Withdrawn

• 1 other identifier: 2016-137
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Insufficiency of Leg; Venous Reflux; Varicose Veins; Lower Extremity Edema Chronic

Keywords

Radiofrequency Ablation; Sclerotherapy; Vasculera

Outcome Measures

Primary Outcomes (4)

• Post-procedure Bruising

  Physician and nurse examination

  2 weeks pre-procedure to 6 weeks post-procedure

• Post-procedure Bleeding

  Physician and nurse examination

  2 weeks pre-procedure to 6 weeks post-procedure

• Post-procedure Pain

  Pain scale

  2 weeks pre-procedure to 6 weeks post-procedure

• Post-procedure Edema

  Physician and nurse examination

  2 weeks pre-procedure to 6 weeks post-procedure

Secondary Outcomes (2)

• Adverse Events

  2 weeks pre-procedure to 6 weeks post-procedure

• Serious Adverse Events

  2 weeks pre-procedure to 6 weeks post-procedure

Study Arms (2)

Active Vasculera (diosmiplex)

ACTIVE COMPARATOR

Active Vasculera will be prescribed as one (1) tablet (630 mg) twice a day.

Other: Vasculera

Vasculera Placebo

PLACEBO COMPARATOR

Vasculera Placebo will be prescribed as one (1) tablet twice a day.

Other: Placebo

Interventions

Vasculera OTHER

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.

Also known as: Diosmiplex, Prescription medical food product

Active Vasculera (diosmiplex)

Placebo OTHER

Vasculera Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Corewell Health West: lead
• Primus Pharmaceuticals: collaborator

Study Sites (1)

Spectrum Health Hospitals

Grand Rapids, Michigan, 49503, United States

Location

Related Publications (11)

• Brand FN, Dannenberg AL, Abbott RD, Kannel WB. The epidemiology of varicose veins: the Framingham Study. Am J Prev Med. 1988 Mar-Apr;4(2):96-101.

  PMID: 3395496 BACKGROUND

• Callam MJ. Epidemiology of varicose veins. Br J Surg. 1994 Feb;81(2):167-73. doi: 10.1002/bjs.1800810204.

  PMID: 8156326 BACKGROUND

• 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.

  PMID: 19648874 BACKGROUND

• 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.

  PMID: 16193222 BACKGROUND

• 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.

  PMID: 8798349 BACKGROUND

• 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.

  PMID: 25514922 BACKGROUND

• 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. doi: 10.2165/00003495-200363010-00005.

  PMID: 12487623 BACKGROUND

• 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.

  PMID: 11510597 BACKGROUND

• 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.

  PMID: 10550269 BACKGROUND

• 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.

  PMID: 22929677 BACKGROUND

• International Task Force. The management of chronic venous disorders of the leg: an evidence-based report of an international task force. Epidemiology. Phlebology. 1999;14(suppl 1):23-34.

  BACKGROUND

Related Links

• Product website

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jennifer J. Watson, MD

  Corewell Health West

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2016
• First Posted: October 18, 2016
• Study Start: October 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: November 23, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)