NCT01200199

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 13, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

April 21, 2021

Status Verified

April 1, 2021

Enrollment Period

9 months

First QC Date

September 8, 2010

Last Update Submit

April 19, 2021

Conditions

Varicose Veins

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • To establish the treatment effect size of foam sclerotherapy treatment

    8 weeks

Study Arms (1)

Varicose veins

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Varicose veins

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Birmingham, B91 2JL, United Kingdom

Location

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • David Wright, MD

    BTG International Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2010

First Posted

September 13, 2010

Study Start

November 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

April 21, 2021

Record last verified: 2021-04

Locations

GB(1)