Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02936271
Study type Interventional
Source Spectrum Health Hospitals
Contact
Status Withdrawn
Phase N/A
Start date October 2016
Completion date April 1, 2017

See also
  Status Clinical Trial Phase
Completed NCT02441881 - Trial of Radiofrequency Thermo-ablation Treatments of Great Saphenous Varicose Veins (3-RF Study) N/A
Completed NCT03283800 - Copper Impact on Venous Insufficiency and Lipodermatosclerosis N/A
Recruiting NCT02676908 - Optimum Duration of Compression Stockings After Endovenous Varicose Vein Surgery N/A
Withdrawn NCT01203397 - Safety And Efficacy Study Of Topic Mucopolysaccharide Polysulfate In The Superficial Varicose Veins Treatment Phase 3
Withdrawn NCT01426035 - Safety And Efficacy Study Of Topic Mucopolysaccharide Polysulfate Cream In The Superficial Varicose Veins Treatment Phase 3
Recruiting NCT02054325 - Study Protocol Comparing Polidocanol Versus Hypertonic Glucose for Treatment of Reticular Veins Phase 4
Withdrawn NCT03601572 - Hypnoanalgesia in Surgical and Endovenous Treatment of Varicosis
Completed NCT04933591 - Impact of Treatment With VENARUS® on the Level of Monocyte Chemoattractant Protein 1 in Varicose Veins Blood N/A
Active, not recruiting NCT02397226 - Lower Limb Venous Insufficiency and the Effect of Radiofrequency Treatment Versus Open Surgery N/A
Terminated NCT02557542 - Pilot RCT Evaluating a One Stop Vein Clinic N/A
Completed NCT00758420 - Randomized, Single Blind, Placebo Controlled, to Evaluate Efficacy and Safety of Polidocanol Injectable Foam for Treatment of Symptomatic, Visible Varicose Veins With SFJ Incompetence Phase 2/Phase 3
Active, not recruiting NCT00841178 - Endovenous Laser Therapy (EVLT) for Sapheno-Popliteal Incompetence and Short Saphenous Vein (SSV) Reflux: A RCT N/A
Not yet recruiting NCT05508581 - Microwaves Ablation of Varicose Veins N/A
Completed NCT05247333 - Implementation of a Minor Ailment Service in Community Pharmacy Practice N/A
Active, not recruiting NCT04339075 - Registry to Investigate the Efficacy and Safety of VenaBlock VeIn SEaling System for VaRicose Veins in SingApore
Completed NCT03392753 - Mechanochemical Ablation Compared to Cyanoacrylate Adhesive N/A
Recruiting NCT04146168 - Lake Washington Vascular VenaSealâ„¢ Post-Market Evaluation
Recruiting NCT02304146 - Long-term Ultrasound Guided Foam Sclerotherapy Versus Classical Surgical Stripping Study N/A
Completed NCT01200199 - Validity of Electronic Diary for Monitoring Varicose Veins Symptoms
Completed NCT01231373 - Polidocanol Endovenous Microfoam (PEM) Versus Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence Phase 3