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| Name | Class |
|---|---|
| ICON Clinical Research | INDUSTRY |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avotermin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator scar assessment | 7 & 12 months | |
| Patient scar assessment | up to 12 months | |
| Independent scar assessment | 7 & 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Local tolerance | ongoing to 12 months | |
| Adverse events | ongoing to12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter McCollum, MB MCh FRCS | Hull Royal Infirmary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost Limburg | Genk | Belgium | ||||
| Universitair Ziekenhuis Gent |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21618480 | Derived | 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. |
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| Ghent |
| Belgium |
| P Stradinas Clinical University Hospital | Riga | Latvia |
| Kaunas 2nd Clinical Hospital | Kaunas | Lithuania |
| Klaipeda Seaman Hospital | KlaipÄ—da | 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 |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C509044 | TGFB3 protein, human |
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