Status:
WITHDRAWN
Does Minimal Post-operative Compression Affect the Outcome for Endovenous Ablation in Treating Varicose Vein Patients?
Lead Sponsor:
NYC Surgical Associates
Conditions:
Varicose Vein
Venous Insufficiency
Eligibility:
All Genders
18+ years
Brief Summary
In this proposal, the investigators seek to determine whether a reduced compression after endovenous ablation procedure in treating superficial venous insufficiency affects the outcomes. This study in...
Detailed Description
All adults with varicose vein who are here in the investigators clinic to seek for endovenous ablation treatments will be invited to participate in this study. The participation in this research is en...
Eligibility Criteria
Inclusion
- Aged 18 and older
- Diagnosis - symptoms (pain, burning, itching, cramping, heaviness and tiredness of leg, restless leg, swelling leg, etc.) and clinical signs (dilated veins, lipodermatosclerosis, color and texture changes of the skin, edema of leg, wound) correlates with vein diameter \>5.5mm and reflex (\>0.5 sec) in the upright position identified with duplex ultrasound
- Severity/ classification - CEAP(clinical, etiologic, anatomic, and pathophysiologic) 3 or higher
- Fail to a minimum of three months of nonoperative management (leg elevation, avoidance of prolonged standing, weight reduction, daily exercise for 30 min, prescription strength gradient compression garments, NSAIDs\<nonsteroidal antiinflammatory drug\>)
- Post endovenous ablation (VNUS or laser) of the great saphenous vein (GSV) or small saphenous vein (SSV).
Exclusion
- Documented allergy or intolerance to compression hosiery
- Treated vein greater than 8.5 in diameters.
- Previous history of DVT(deep venous thrombosis); Known prothrombotic state.
- Arterial insufficiency as determined by ABI(ankle-brachial index)\<0.5.
- Obesity (BMI \>35, class II).
Key Trial Info
Start Date :
August 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02241707
Start Date
August 1 2014
End Date
August 1 2015
Last Update
April 29 2015
Active Locations (1)
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1
NYC Surgical Associates, 555 Passaic Ave, Suite 10
West Caldwell, New Jersey, United States, 07006