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Sponsors and Collaborators: |
Renovo ICON Clinical Research |
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Information provided by: | Renovo |
ClinicalTrials.gov Identifier: | NCT00430326 |
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.
Condition | Intervention | Phase |
---|---|---|
Varicose Veins Cicatrix |
Drug: Avotermin |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | 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. |
Estimated Enrollment: | 156 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Patients undergoing bilateral removal of the saphenous vein (by ligation and stripping) will be invited to participate in the study. Consenting patients will undergo a detailed screening examination, after which suitability to progress to randomisation to the study will be confirmed.
Suitable screened patients will attend for scheduled surgery of vein removal as normal - this is termed "Day 0" At the time of wound closure, IMP will be administered via intra-dermal injection to each of the incisional groin wounds, and exit wounds.
Each patient will serve as their own control with one leg being administered active IMP (at either a 5, 50, 200 or 500ng/100 ul)of dose solution, whilst the other leg is administered placebo solution. The study is double-blinded, so neither the Investigator nor patient will know which leg wounds receive which treatment.
Further to Day 0, the patients are requested to attend for a further 5 follow up visits (Week 6, Month 3, Month 5, Month 7 & Month 12), where photographs of the scars will be taken, together with spectrophotometry readings to measure colour of the scar. At each visit, the Investigator and patient will rate their opinion of the scar, by global assessment scale & VAS, together with patient completed questionnaires.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Belgium | |
Ziekenhuis Oost Limburg | |
Genk, Belgium | |
Universitair Ziekenhuis Gent | |
Gent, Belgium | |
Latvia | |
P Stradinas Clinical University Hospital | |
Riga, Latvia | |
Lithuania | |
Kaunas 2nd Clinical Hospital | |
Kaunas, Lithuania | |
Vilnius City University Hospital | |
Vilnius, Lithuania | |
Klaipeda Seaman Hospital | |
Klaipeda, Lithuania | |
United Kingdom | |
Hull Royal Infirmary | |
Hull, United Kingdom, HU3 2JZ | |
Derby City General Hospital | |
Derby, United Kingdom, DE22 3NE | |
Heartlands Hospital | |
Birmingham, United Kingdom, B9 5SS | |
Freeman Hospital | |
Newcastle, United Kingdom, NE7 7DN | |
Wythenshawe Hospital | |
Manchester, United Kingdom, M23 9LT | |
Royal Bournemouth Hospital | |
Bournemouth, United Kingdom, BH7 7DW | |
St Georges Hospital | |
London, United Kingdom, SW17 0OT | |
Leeds General Infirmary | |
Leeds, United Kingdom, LS1 3EX | |
Gloucester Royal Hospital | |
Gloucester, United Kingdom, GL1 3NN | |
Belfast City Hospital | |
Belfast, United Kingdom, BT9 7AB | |
Royal Infirmary of Edinburgh | |
Edinburgh, United Kingdom, EH16 4SA | |
Bristol Royal Infirmary | |
Bristol, United Kingdom, BS2 8HW | |
Russells Hall Hospital | |
Dudley, United Kingdom, DY1 2HQ | |
St Mary's Hospital | |
London, United Kingdom, W2 1NY | |
Norfolk & Norwich University Hospital | |
Norwich, United Kingdom, NR4 7UY |
Principal Investigator: | Peter McCollum, MB MCh FRCS | Hull Royal Infirmary |
Responsible Party: | Renovo ( Julia Day, Clinical Trial Manager ) |
Study ID Numbers: | RN1001-0042 |
Study First Received: | January 31, 2007 |
Last Updated: | October 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00430326 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Skin Diseases Varicose Veins Vascular Diseases Cicatrix |
Cardiovascular Diseases |