Clinical trial NCT00430326: Juvista (Avotermin) in Scars Following Varicose Vein Removal
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Varicose Veins
Cicatrix
Lead sponsor: Renovo
Sponsor class: INDUSTRY
Collaborators: name: ICON Clinical Research
First posted: 2007-02-01
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Investigator scar assessment
timeFrame: 7 & 12 months
measure: Patient scar assessment
timeFrame: up to 12 months
measure: Independent scar assessment
timeFrame: 7 & 12 months
Secondary outcomes:
measure: Local tolerance
timeFrame: ongoing to 12 months
measure: Adverse events
timeFrame: ongoing to12 months
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost Limburg
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Riga
country: Latvia
facility: P Stradinas Clinical University Hospital
city: Kaunas
country: Lithuania
facility: Kaunas 2nd Clinical Hospital
city: Klaipeda
country: Lithuania
facility: Klaipeda Seaman Hospital
city: Vilnius
country: Lithuania
facility: Vilnius City University Hospital
city: Belfast
country: United Kingdom
facility: Belfast City Hospital
city: Birmingham
country: United Kingdom
facility: Heartlands Hospital
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
city: Bristol
country: United Kingdom
facility: Bristol Royal Infirmary
city: Derby
country: United Kingdom
facility: Derby City General Hospital
city: Dudley
country: United Kingdom
facility: Russells Hall Hospital
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
city: Gloucester
country: United Kingdom
facility: Gloucester Royal Hospital
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: London
country: United Kingdom
facility: St Georges Hospital
city: London
country: United Kingdom
facility: St Mary's Hospital
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital
city: Newcastle
country: United Kingdom
facility: Freeman Hospital
city: Norwich
country: United Kingdom
facility: Norfolk & Norwich University Hospital
Study officials:
affiliation: Hull Royal Infirmary
name: Peter McCollum, MB MCh FRCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.