RecruitingPhase 1ACTRN12606000056594

Recurrence of varicose veins following superficial venous surgery: prevention using doxycycline


Sponsor

Department of Surgery, Dunedin school of medicine.

Enrollment

10 participants

Start Date

Feb 1, 2006

Study Type

Interventional

Conditions

Summary

Double blinding:Main study only: Patients will be given doxycycline or placebo in identical bottles. Research staff involved in measurements will not be aware of the group getting doxycycline, although doctors involved in care of patient (eg GPs) will be notified. Primary goal of the main study will be to determine whether doxycycline is able to prevent neovascularisation in patients following superficial venous surgery.


Eligibility

Sex: Both males and femalesMin Age: 16 YearssMax Age: 75 Yearss

Inclusion Criteria1

  • Pilot study: Patients aged undergoing elective abdominal aortic aneurysm repair. Main study: Patients undergoing varicose vein surgery including saphenofemoral ligation.

Exclusion Criteria1

  • Life expectancy less than 2 years after surgery, inaccessible distance from Dunedin, severe immobility, previous adverse reaction to doxycycline or other tetracycline derivative.

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Interventions

Pilot study: A randomised controlled double blind study of the use of doxycycline to affect levels of CD34 positive cells, VEGF, MMP-9 and other factors following abdominal aortic aneurysm repair. Gr

Pilot study: A randomised controlled double blind study of the use of doxycycline to affect levels of CD34 positive cells, VEGF, MMP-9 and other factors following abdominal aortic aneurysm repair. Grp A: patients will take doxycycline (100mg twice daily) for one week prior to surgery and 4 weeks post operatively. Grp B: patients will take doxycycline (100mg twice daily) beginning on the day of surgery and for 4 weeks post operatively. Blood samples will be taken prior to, during and after doxycycline administration. Tissue samples will be obtained following surgery. Main study: A randomised controlled double blind study of the use of doxycycline to affect levels of CD34 positive cells, VEGF, MMP-9 and other factors following superficial venous surgery for varicose veins. Details of this study will be expanded on when results of the pilot study have been analysed. Follow up of all patients with ultrasound, air plethysmography and clinical evaluation at 1 month, 6 months, 1, 3 and 5 years.


Locations(1)

New Zealand

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ACTRN12606000056594