Validity of Electronic Diary for Monitoring Varicose Veins Symptoms

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

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Key information

Conditions

Varicose Veins Cardiovascular Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Birmingham, B91 2JL, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

Performance of Daily Electronic Diary to Capture Venous Symptoms Before and After Intervention for Great Saphenous Vein Incompetence

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Sep 13, 2010
Registry last updated: Apr 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed