Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00430326
Status:
COMPLETED
Last Update Posted:
2010-03-09
First Post:
2007-01-31
Brief Title:
Juvista Avotermin in Scars Following Varicose Vein Removal
Sponsor:
Renovo
Organization:
Renovo
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
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 500ng100 ulof 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
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 500ng100 ulof 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None