Recurrence of varicose veins following superficial venous surgery: prevention using doxycycline
Phase 1
Recruiting
- Conditions
- Recurrence of varicose veinsCardiovascular - Diseases of the vasculature and circulation including the lymphatic system
- Registration Number
- ACTRN12606000056594
- Lead Sponsor
- Department of Surgery, Dunedin school of medicine.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
Pilot study: Patients aged undergoing elective abdominal aortic aneurysm repair. Main study: Patients undergoing varicose vein surgery including saphenofemoral ligation.
Exclusion Criteria
Life expectancy less than 2 years after surgery, inaccessible distance from Dunedin, severe immobility, previous adverse reaction to doxycycline or other tetracycline derivative.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main study: The recurrence of ultrasound detected venous reflux at the ligated saphenofemoral junction site in the groin due to neovascularisation.[Outcome measured at one month, 6 months, 1 year and 3 years post surgery, with a possible 5 years follow up as well (unknown at this point)];Pilot study: Primary outcome: patient tolerance of long-term doxycycline administration.[Tolerance will be monitored on a week to week basis during doxycycline administration, with patients to contact research staff if they experience any problems in between visits.]
- Secondary Outcome Measures
Name Time Method Main study secondary outcomes:a: Clinical recurrence, venous clinical severity score, patient satisfaction questionnaire, perforator recurrence after ligation. <br>Levels of the factors mentioned above will be measured while the administration of doxycycline is ongoing.[Outcome measured at one month, 6 months, 1 year and 3 years post surgery and possibly 5 years (unknown at this time point).];Pilot study: Measurement of CD34 positive cells, VEGF levels, MMP-9 levels prior.[During and post surgery at one week intervals.]