Status:
COMPLETED
Validity of Electronic Diary for Monitoring Varicose Veins Symptoms
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Varicose Veins
Eligibility:
All Genders
18-75 years
Brief Summary
The purpose of this study is to contribute to the validation of an electronic daily diary to assess symptoms in patients with varicose veins.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01200199
Start Date
November 1 2010
End Date
August 1 2011
Last Update
April 21 2021
Active Locations (1)
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1
Birmingham, United Kingdom, B91 2JL