Validity of Electronic Diary for Monitoring Varicose Veins Symptoms

Boston Scientific

Status: Completed

Conditions: Varicose Veins

Study type: Observational

Funder types: Industry

Identifiers

NCT01200199

RS-002

Details and patient eligibility

About

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

Enrollment: 45 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

45 participants in 1 patient group

Varicose veins