Clinical Trials Logo
  1. Home
  2. Varicose Veins
  3. 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 — Pilot  

Varicose Veins Clinical Trial

Official title:
A Randomized, Single Blind, Placebo Controlled, Multicenter Study to Evaluate Efficacy and Safety of Polidocanol Injectable Foam for the Treatment of Symptomatic, Visible Varicose Veins With Saphenofemoral Junction (SFJ) Incompetence.

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness of polidocanol injectable foam in the relief of symptoms, improvement of appearance, and overall effectiveness and safety in the treatment of varicose veins compared to placebo.

Clinical Trial Description

The purpose of this study is to evaluate the efficacy of polidocanol injectable foam vs placebo treatments in relief of symptoms using two disease specific questionnaires, establishment of a minimally important difference (MID) for the questionnaires, improvement in the appearance of visible varicosities by a patient and medical assessments aided by pre and post treatment photographs, and a central independent assessor evaluating pre and post treatment photographs. In addition, the study will evaluate the efficacy of polidocanol injectable foam vs the placebo treatment in the elimination of SFJ reflux or occlusion of the treated vein, and to determine whether the placebo procedure blinds the patient to treatment assignment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00758420
Study type Interventional
Source Boston Scientific Corporation
Contact
Status Completed
Phase Phase 2/Phase 3
Start date October 2008
Completion date August 2009
View Details
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Withdrawn NCT01426035 - Safety And Efficacy Study Of Topic Mucopolysaccharide Polysulfate Cream In The Superficial Varicose Veins Treatment Phase 3
Withdrawn NCT01203397 - Safety And Efficacy Study Of Topic Mucopolysaccharide Polysulfate In The Superficial Varicose Veins Treatment Phase 3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
Withdrawn NCT02936271 - Efficacy of Vasculera in Prevention on Post-op Pain and Edema Following Lower Extremity Venous Treatment in the Outpatient Setting N/A
Terminated NCT02557542 - Pilot RCT Evaluating a One Stop Vein Clinic N/A
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 VenaSeal™ 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