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Validity of Electronic Diary for Monitoring Varicose Veins Symptoms

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01200199
First Posted: September 13, 2010
Last Update Posted: March 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
BTG International Inc.
  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:


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 ]

Secondary Outcome Measures:
  • To establish the treatment effect size of foam sclerotherapy treatment [ Time Frame: 8 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01200199


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

Responsible Party: BTG International Inc.
ClinicalTrials.gov Identifier: NCT01200199     History of Changes
Other Study ID Numbers: RS-002
First Submitted: September 8, 2010
First Posted: September 13, 2010
Last Update Posted: March 11, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Varicose Veins
Vascular Diseases
Cardiovascular Diseases