Clinical Trials Logo
  1. Home
  2. Varicose Veins
  3. NCT02657252

Polidocanol Versus Glucose Treatment of Telangiectasia Trial — PG3T  

Varicose Veins Clinical Trial

Official title:
Polidocanol Versus Glucose For Sclerotherapy Treatment Of Telangiectasia Of The Lower Limbs: Protocol For A Randomized, Controlled Clinical Trial

Clinical Trial Summary

It will be done a randomized triple-blind study comparing 0,2% polidocanol versus 75% hypertonic glucose of sclerotherapy in lower limbs´ telangiectasis. It will be included only adult women with reticular veins on the side of the thighs and mild venous insufficiency (CEAP 1). The primary endpoint will be efficacy, and secondary will be safety.

Clinical Trial Description

Background. The prevalence of chronic venous disease is high in the general population, mainly in young women, and in milder cases the usual complaint is aesthetic. Various techniques are used for treatment of mild varicose disease, including surgical treatment, laser ablation and sclerotherapy. Telangiectasis are those with less than 1 mm diameter, reddish and important contribution to the aesthetic damage, and sometimes they are related to local pain. There is no consensus in the literature about the effectiveness of treatment with sclerotherapy, despite of being an usual procedure with different chemicals.

Methods and design. One hundred lower limbs of healthy women between 18 and 65 years will be triple blind randomized to receive treatment with polidocanol 0.2% diluted in 70% hypertonic glucose versus 75% hypertonic glucose for sclerotherapy treatment of telangiectasis. The patients will be examined and clinically classified. It will be included patients with telangiectasis sited at out's thigh, and only one extremity will be included per patient. The patients with varicose disease CEAP 2 or more will not be included. The treatment will be carried out in only one session and the medication volume not exceeding 5 ml. Clinical follow-up protocols will be filled on regular visits on days 0 - 7 - 60 concomitantly with photograph documentation. Supplementary examination for venous mapping with ultrasound pretreatment is performed for all patients.

Discussion. This prospective controlled double-blind randomized trial aims to verify and compare the efficacy and safety for sclerotherapy treatment of telangiectasis of the lower limbs. The results may help physicians to choose the best sclerotherapy treatment for telangiectasis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02657252
Study type Interventional
Source UPECLIN HC FM Botucatu Unesp
Contact
Status Completed
Phase Phase 4
Start date January 2015
Completion date November 2016
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 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
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
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 VenaSeal™ Post-Market Evaluation
Recruiting NCT02304146 - Long-term Ultrasound Guided Foam Sclerotherapy Versus Classical Surgical Stripping Study N/A
Completed NCT01231373 - Polidocanol Endovenous Microfoam (PEM) Versus Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence Phase 3