Juvista (Avotermin) in Scars Following Varicose Vein Removal
A Dose Response Trial to Investigate the Efficacy of Juvista (Avotermin) in the Improvement of Scar Appearance When Applied to Approximated Wound Margins Following Bilateral Varicose Vein Removal.
1 other identifier
interventional
156
4 countries
21
Brief Summary
This trial is being undertaken to investigate the efficacy and safety of Juvista in the improvement of scar appearance when administered to approximated wound margins following varicose vein surgery. The results from this trial will be used to select doses for investigation in future clinical trials with the compound.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2006
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 31, 2007
CompletedFirst Posted
Study publicly available on registry
February 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedMarch 9, 2010
March 1, 2010
2.2 years
January 31, 2007
March 8, 2010
Conditions
Outcome Measures
Primary Outcomes (3)
Investigator scar assessment
7 & 12 months
Patient scar assessment
up to 12 months
Independent scar assessment
7 & 12 months
Secondary Outcomes (2)
Local tolerance
ongoing to 12 months
Adverse events
ongoing to12 months
Interventions
Eligibility Criteria
You may qualify if:
- Male and female patients between 18 and 85 years of age.
- Patients undergoing surgical removal of bilateral varicose veins by ligation and stripping, which will result in clinically similar (i.e. size and location) wounds at the groin and knee.
- Patients who have provided written informed consent.
- Patients with a body mass index between 15 and 35 kg/m2 inclusive.
- Patients with, in the opinion of the Investigator, clinically acceptable results for the laboratory tests specified in the trial protocol (see Protocol Section 6.4.1).
- Female patients of child bearing potential using method(s) of contraception acceptable to the Investigator and who agree to do so from at least the screening visit until one month after administration of the Investigational Medicinal Product.
You may not qualify if:
- Patients who have had previous surgical treatment for varicose veins.
- Patients with a history of a bleeding disorder.
- Patients with a chronic or currently active skin disorder which may adversely affect the healing of the acute wounds or involves the areas to be examined in this trial.
- Patients who on direct questioning and/or physical examination, have evidence of any past or present clinically significant medical condition that would impair wound healing.
- Patients who are taking or have taken investigational drugs in the 3 months prior to the screening visit.
- Patients with existing scars within 3cm of the potential trial wounds.
- Patients with diseases or conditions that could, in the opinion of the Investigator, interfere with the assessment of safety, tolerability or efficacy of the Investigational Product.
- Patients with a history of clinically significant hypersensitivity to any of the drugs or surgical dressings to be used in this trial.
- Patients who are taking regular, continuous, oral corticosteroid therapy.
- Patients undergoing investigations or changes in management for an existing medical condition.
- Patients who are pregnant or lactating.
- Patients who, in the opinion of the Investigator, are not likely to complete the trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Renovolead
- ICON Clinical Researchcollaborator
Study Sites (21)
Ziekenhuis Oost Limburg
Genk, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
P Stradinas Clinical University Hospital
Riga, Latvia
Kaunas 2nd Clinical Hospital
Kaunas, Lithuania
Klaipeda Seaman Hospital
Klaipėda, Lithuania
Vilnius City University Hospital
Vilnius, Lithuania
Belfast City Hospital
Belfast, BT9 7AB, United Kingdom
Heartlands Hospital
Birmingham, B9 5SS, United Kingdom
Royal Bournemouth Hospital
Bournemouth, BH7 7DW, United Kingdom
Bristol Royal Infirmary
Bristol, BS2 8HW, United Kingdom
Derby City General Hospital
Derby, DE22 3NE, United Kingdom
Russells Hall Hospital
Dudley, DY1 2HQ, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA, United Kingdom
Gloucester Royal Hospital
Gloucester, GL1 3NN, United Kingdom
Hull Royal Infirmary
Hull, HU3 2JZ, United Kingdom
Leeds General Infirmary
Leeds, LS1 3EX, United Kingdom
St Georges Hospital
London, SW17 0OT, United Kingdom
St Mary's Hospital
London, W2 1NY, United Kingdom
Wythenshawe Hospital
Manchester, M23 9LT, United Kingdom
Freeman Hospital
Newcastle, NE7 7DN, United Kingdom
Norfolk & Norwich University Hospital
Norwich, NR4 7UY, United Kingdom
Related Publications (1)
McCollum PT, Bush JA, James G, Mason T, O'Kane S, McCollum C, Krievins D, Shiralkar S, Ferguson MW. Randomized phase II clinical trial of avotermin versus placebo for scar improvement. Br J Surg. 2011 Jul;98(7):925-34. doi: 10.1002/bjs.7438. Epub 2011 Mar 29.
PMID: 21618480DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter McCollum, MB MCh FRCS
Hull Royal Infirmary
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 31, 2007
First Posted
February 1, 2007
Study Start
November 1, 2006
Primary Completion
January 1, 2009
Study Completion
April 1, 2009
Last Updated
March 9, 2010
Record last verified: 2010-03