Validity of Electronic Diary for Monitoring Varicose Veins Symptoms

This study has been completed.
Information provided by (Responsible Party):
BTG International Inc. ( BTG Ltd. ) Identifier:
First received: September 8, 2010
Last updated: March 7, 2013
Last verified: March 2013

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

Varicose Veins

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Performance of Daily Electronic Diary to Capture Venous Symptoms Before and After Intervention for Great Saphenous Vein Incompetence

Resource links provided by NLM:

Further study details as provided by BTG International Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To establish the treatment effect size of foam sclerotherapy treatment [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: November 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Varicose veins


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Varicose veins


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
  Contacts and Locations
Please refer to this study by its identifier: NCT01200199

United Kingdom
Birmingham, United Kingdom, B91 2JL
Sponsors and Collaborators
BTG Ltd.
Study Director: David Wright, MD BTG International Inc.
  More Information

No publications provided

Responsible Party: BTG International Inc. ( BTG Ltd. ) Identifier: NCT01200199     History of Changes
Other Study ID Numbers: RS-002
Study First Received: September 8, 2010
Last Updated: March 7, 2013
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Varicose Veins
Vascular Diseases
Cardiovascular Diseases processed this record on April 16, 2014