Validity of Electronic Diary for Monitoring Varicose Veins Symptoms

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01200199

Enrollment

Registered

2010-09-13

Start date

2010-11-30

Completion date

2011-08-31

Last updated

2021-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Varicose Veins

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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	8 weeks

Secondary

Measure	Time frame
To establish the treatment effect size of foam sclerotherapy treatment	8 weeks

Countries

United Kingdom

Outcome results