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

NCT02936271 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-11-23

No results posted yet for this study

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

Interventions

OTHER

Vasculera

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.

OTHER

Placebo

Sponsors & Collaborators

  • Primus Pharmaceuticals

    collaborator INDUSTRY

  • Spectrum Health Hospitals

    lead OTHER

Principal Investigators

  • Jennifer J. Watson, MD · Spectrum Health Hospitals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2017-04-01
Completion
2017-04-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02936271 on ClinicalTrials.gov