Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000056594
Ethics application status
Approved
Date submitted
30/01/2006
Date registered
8/02/2006
Date last updated
8/02/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Recurrence of varicose veins following superficial venous surgery: prevention using doxycycline
Scientific title
Recurrence of varicose veins following superficial venous surgery: prevention using doxycycline
Universal Trial Number (UTN)
Trial acronym
Prevention of recurrent varicose veins
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrence of varicose veins 1020 0
Condition category
Condition code
Cardiovascular 1096 1096 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 870 0
Prevention
Comparator / control treatment
doxycycline (100mg twice daily )for 4 weeks
Control group
Active

Outcomes
Primary outcome [1] 1463 0
Main study: The recurrence of ultrasound detected venous reflux at the ligated saphenofemoral junction site in the groin due to neovascularisation.
Timepoint [1] 1463 0
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)
Primary outcome [2] 1464 0
Pilot study: Primary outcome: patient tolerance of long-term doxycycline administration.
Timepoint [2] 1464 0
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 [1] 2623 0
Main study secondary outcomes:a: Clinical recurrence, venous clinical severity score, patient satisfaction questionnaire, perforator recurrence after ligation.
Levels of the factors mentioned above will be measured while the administration of doxycycline is ongoing.
Timepoint [1] 2623 0
Outcome measured at one month, 6 months, 1 year and 3 years post surgery and possibly 5 years (unknown at this time point).
Secondary outcome [2] 2624 0
Pilot study: Measurement of CD34 positive cells, VEGF levels, MMP-9 levels prior.
Timepoint [2] 2624 0
During and post surgery at one week intervals.

Eligibility
Key inclusion criteria
Pilot study: Patients aged undergoing elective abdominal aortic aneurysm repair. Main study: Patients undergoing varicose vein surgery including saphenofemoral ligation.
Minimum age
16 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation: Not recorded in patients laboratory notes, not recorded in research follow up protocols, not communicated to staff involved with various outcome measures. Envelopes, which contain the number indicating the type of treatment the patient will receive will be opened at the appropriate time prior to surgery. An independant person will randomise, administrate and maintain the randomisation and code until analyses complete.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation by random numbers (computer generated) in blocks for each participating surgeon. Envelopes, which contain the number indicating the type of treatment the patient will receive will be opened at the appropriate time prior to surgery. An independent person will randomise, administrate and maintain the randomisation and code until analyses complete.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 266 0
New Zealand
State/province [1] 266 0

Funding & Sponsors
Funding source category [1] 1199 0
University
Name [1] 1199 0
Department of surgery, Dunedin School of Medicine
Country [1] 1199 0
New Zealand
Funding source category [2] 1200 0
Other
Name [2] 1200 0
Lawrence Award
Country [2] 1200 0
Primary sponsor type
University
Name
Department of Surgery, Dunedin school of medicine.
Address
Country
New Zealand
Secondary sponsor category [1] 1059 0
None
Name [1] 1059 0
None
Address [1] 1059 0
Country [1] 1059 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2539 0
Southern Regional Ethics Committee
Ethics committee address [1] 2539 0
Ethics committee country [1] 2539 0
New Zealand
Date submitted for ethics approval [1] 2539 0
Approval date [1] 2539 0
Ethics approval number [1] 2539 0

Summary
Brief 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35970 0
Address 35970 0
Country 35970 0
Phone 35970 0
Fax 35970 0
Email 35970 0
Contact person for public queries
Name 10059 0
Samantha Dutton
Address 10059 0
Department of Surgery
Dunedin School of Medicine
PO Box 913
Dunedin
Country 10059 0
New Zealand
Phone 10059 0
+64 3 4740999 ext. 8836
Fax 10059 0
Email 10059 0
samantha.dutton@stonebow.otago.ac.nz
Contact person for scientific queries
Name 987 0
Professor Andre van Rij
Address 987 0
Department of Surgery
Dunedin School of Medicine
PO Box 913
Dunedin
Country 987 0
New Zealand
Phone 987 0
+64 3 4740999 ext. 8834
Fax 987 0
Email 987 0
andre.vanrij@stonebow.otago.ac.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
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Documents added automatically
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