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Juvista (Avotermin) in Scars Following Varicose Vein Removal

Primary Purpose

Varicose Veins, Cicatrix

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Avotermin
Sponsored by
Renovo
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Varicose Veins

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ziekenhuis Oost Limburg
  • Universitair Ziekenhuis Gent
  • P Stradinas Clinical University Hospital
  • Kaunas 2nd Clinical Hospital
  • Klaipeda Seaman Hospital
  • Vilnius City University Hospital
  • Belfast City Hospital
  • Heartlands Hospital
  • Royal Bournemouth Hospital
  • Bristol Royal Infirmary
  • Derby City General Hospital
  • Russells Hall Hospital
  • Royal Infirmary of Edinburgh
  • Gloucester Royal Hospital
  • Hull Royal Infirmary
  • Leeds General Infirmary
  • St Georges Hospital
  • St Mary's Hospital
  • Wythenshawe Hospital
  • Freeman Hospital
  • Norfolk & Norwich University Hospital

Outcomes

Primary Outcome Measures

Investigator scar assessment
Patient scar assessment
Independent scar assessment

Secondary Outcome Measures

Local tolerance
Adverse events

Full Information

First Posted
January 31, 2007
Last Updated
March 8, 2010
Sponsor
Renovo
Collaborators
ICON Clinical Research
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1. Study Identification

Unique Protocol Identification Number
NCT00430326
Brief Title
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

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Renovo
Collaborators
ICON Clinical Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Veins, Cicatrix

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
156 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Avotermin
Primary Outcome Measure Information:
Title
Investigator scar assessment
Time Frame
7 & 12 months
Title
Patient scar assessment
Time Frame
up to 12 months
Title
Independent scar assessment
Time Frame
7 & 12 months
Secondary Outcome Measure Information:
Title
Local tolerance
Time Frame
ongoing to 12 months
Title
Adverse events
Time Frame
ongoing to12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter McCollum, MB MCh FRCS
Organizational Affiliation
Hull Royal Infirmary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ziekenhuis Oost Limburg
City
Genk
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
Country
Belgium
Facility Name
P Stradinas Clinical University Hospital
City
Riga
Country
Latvia
Facility Name
Kaunas 2nd Clinical Hospital
City
Kaunas
Country
Lithuania
Facility Name
Klaipeda Seaman Hospital
City
Klaipeda
Country
Lithuania
Facility Name
Vilnius City University Hospital
City
Vilnius
Country
Lithuania
Facility Name
Belfast City Hospital
City
Belfast
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
Heartlands Hospital
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Bristol Royal Infirmary
City
Bristol
ZIP/Postal Code
BS2 8HW
Country
United Kingdom
Facility Name
Derby City General Hospital
City
Derby
ZIP/Postal Code
DE22 3NE
Country
United Kingdom
Facility Name
Russells Hall Hospital
City
Dudley
ZIP/Postal Code
DY1 2HQ
Country
United Kingdom
Facility Name
Royal Infirmary of Edinburgh
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Facility Name
Gloucester Royal Hospital
City
Gloucester
ZIP/Postal Code
GL1 3NN
Country
United Kingdom
Facility Name
Hull Royal Infirmary
City
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Facility Name
Leeds General Infirmary
City
Leeds
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Facility Name
St Georges Hospital
City
London
ZIP/Postal Code
SW17 0OT
Country
United Kingdom
Facility Name
St Mary's Hospital
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Facility Name
Wythenshawe Hospital
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Norfolk & Norwich University Hospital
City
Norwich
ZIP/Postal Code
NR4 7UY
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
21618480
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.
Results Reference
derived

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Juvista (Avotermin) in Scars Following Varicose Vein Removal

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