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Validity of Electronic Diary for Monitoring Varicose Veins Symptoms

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BTG Ltd.
ClinicalTrials.gov Identifier:
NCT01200199
First received: September 8, 2010
Last updated: March 7, 2013
Last verified: March 2013
History of Changes
  Purpose

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


Condition
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:

MedlinePlus related topics: Varicose Veins
U.S. FDA Resources

Further study details as provided by BTG Ltd.:

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)
Groups/Cohorts
Varicose veins

  Eligibility

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

Criteria

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 ClinicalTrials.gov identifier: NCT01200199

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

No publications provided

Responsible Party: BTG Ltd.
ClinicalTrials.gov 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

ClinicalTrials.gov processed this record on May 23, 2013