Validity of Electronic Diary for Monitoring Varicose Veins Symptoms
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To assess the feasibility, variability, validity and sensitivity of patient's varicose vein symptoms using a disease-specific symptom questionnaire, administered as a daily electronic diary in patients undergoing treatment for varicose veins [ Time Frame: 8 weeks ]
Secondary Outcome Measures
To establish the treatment effect size of foam sclerotherapy treatment [ Time Frame: 8 weeks ]
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Ages Eligible for Study:
18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Sign informed consent and complete study assessments in written English
Male or female age 18 to 75
Patients having Saphenofemoral Junction (SFJ) incompetence and scheduled to receive foam sclerotherapy treatment for varicose veins in one leg
Screening Symptom score of 7 points or more as measured by Question 1 on the modified VEINES-QOL/Sym questionnaire
Unable to comply with completing a daily diary for a total of 24 days
Participation in any other investigational pharmaceutical product, or device study within the 3 months prior to Visit 1