Varicose VeinsPhase 2NCT00430326
Juvista (Avotermin) in Scars Following Varicose Vein Removal
A Phase 2 study testing Avotermin in people with Varicose Veins and Cicatrix, run by Renovo at 21 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Varicose Veins, Cicatrix
- What is being tested?
- Avotermin
- How many people
- 156 participants
- Where
- 21 sitesin 4 countries
- Study dates
- Nov 2006to Apr 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
21 sites in 4 countries.
21 sites in 4 countries
United Kingdom15 sites
Belfast City Hospital
Belfast, BT9 7AB
Heartlands Hospital
Birmingham, B9 5SS
Royal Bournemouth Hospital
Bournemouth, BH7 7DW
Bristol Royal Infirmary
Bristol, BS2 8HW
Derby City General Hospital
Derby, DE22 3NE
Russells Hall Hospital
Dudley, DY1 2HQ
Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA
Gloucester Royal Hospital
Gloucester, GL1 3NN
Hull Royal Infirmary
Hull, HU3 2JZ
Leeds General Infirmary
Leeds, LS1 3EX
St Georges Hospital
London, SW17 0OT
St Mary's Hospital
London, W2 1NY
Wythenshawe Hospital
Manchester, M23 9LT
Freeman Hospital
Newcastle, NE7 7DN
Norfolk & Norwich University Hospital
Norwich, NR4 7UY
Lithuania3 sites
Kaunas 2nd Clinical Hospital
Kaunas
Klaipeda Seaman Hospital
Klaipėda
Vilnius City University Hospital
Vilnius
About this 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.
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.
Read the 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 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.
- Conditions
- Varicose Veins, Cicatrix
- Being tested
- Avotermin
- Medical subject headings
- Varicose Veins, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvoterminDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator scar assessment
Measured: 7 & 12 months
Patient scar assessment
Measured: up to 12 months
Independent scar assessment
Measured: 7 & 12 months
Secondary outcomes (2)
Local tolerance
Measured: ongoing to 12 months
Adverse events
Measured: ongoing to12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2007 (estimated)
- Study startNov 2006
- Primary completionJan 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renovo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON Clinical Research
- Investigators
- Peter McCollum, MB MCh FRCS, Principal investigator, Hull Royal Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00430326
- Sponsor's protocol ID
- RN1001-0042
- Status last verified
- Mar 2010
- First submitted
- 31 Jan 2007
- Last updated
- 9 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21618480
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00430326
- Acronym / sponsor ID
- RN1001-0042
- Conditions
- Varicose Veins, Cicatrix
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- RenovoIndustry (pharma, biotech, devices)
- Collaborators
- ICON Clinical Research
- Study start
- Nov 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 1 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avotermin | Drug | – |
Primary outcome
Investigator scar assessment
Time frame: 7 & 12 months
Patient scar assessment
Time frame: up to 12 months
Independent scar assessment
Time frame: 7 & 12 months
2 secondary outcomes
Local tolerance
Time frame: ongoing to 12 months
Adverse events
Time frame: ongoing to12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2010.
- Derived from this study: PubMed 21618480McCollum 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter McCollum, MB MCh FRCS principal investigator
Hull Royal Infirmary
21 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Avotermin in people with Varicose Veins and Cicatrix, run by Renovo at 21 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United Kingdom, Lithuania, Belgium, Latvia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator scar assessment (time frame: 7 & 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00430326, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2010.