Validity of Electronic Diary for Monitoring Varicose Veins Symptoms

N/ACompletedNCT01200199

Boston Scientific Corporation45 enrolled

Overview

The purpose of this study is to contribute to the validation of an electronic daily diary to assess symptoms in patients with varicose veins.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Varicose Veins

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Current venous leg ulcer in either leg

Locations (1)

Unnamed facility

Birmingham, United Kingdom

Outcomes

Primary Outcomes

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 Outcomes

To establish the treatment effect size of foam sclerotherapy treatment

Time frame: 8 weeks

Data from ClinicalTrials.gov

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