Juvista (Avotermin) in Scars Following Varicose Vein Removal

March 8, 2010 updated by: Renovo

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

156

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Genk, Belgium
        • Ziekenhuis Oost Limburg
      • Gent, Belgium
        • Universitair Ziekenhuis Gent
  • Latvia
      • Riga, Latvia
        • P Stradinas Clinical University Hospital
  • Lithuania
      • Kaunas, Lithuania
        • Kaunas 2nd Clinical Hospital
      • Klaipeda, Lithuania
        • Klaipeda seaman hospital
      • Vilnius, Lithuania
        • Vilnius City University Hospital
  • United Kingdom
      • Belfast, United Kingdom, BT9 7AB
        • Belfast City Hospital
      • Birmingham, United Kingdom, B9 5SS
        • Heartlands Hospital
      • Bournemouth, United Kingdom, BH7 7DW
        • Royal Bournemouth Hospital
      • Bristol, United Kingdom, BS2 8HW
        • Bristol Royal Infirmary
      • Derby, United Kingdom, DE22 3NE
        • Derby City General Hospital
      • Dudley, United Kingdom, DY1 2HQ
        • Russells Hall Hospital
      • Edinburgh, United Kingdom, EH16 4SA
        • Royal Infirmary of Edinburgh
      • Gloucester, United Kingdom, GL1 3NN
        • Gloucester Royal Hospital
      • Hull, United Kingdom, HU3 2JZ
        • Hull Royal Infirmary
      • Leeds, United Kingdom, LS1 3EX
        • Leeds General Infirmary
      • London, United Kingdom, W2 1NY
        • St Mary's Hospital
      • London, United Kingdom, SW17 0OT
        • St Georges Hospital
      • Manchester, United Kingdom, M23 9LT
        • Wythenshawe Hospital
      • Newcastle, United Kingdom, NE7 7DN
        • Freeman Hospital
      • Norwich, United Kingdom, NR4 7UY
        • Norfolk & Norwich University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Investigator scar assessment
Time Frame: 7 & 12 months
7 & 12 months
Patient scar assessment
Time Frame: up to 12 months
up to 12 months
Independent scar assessment
Time Frame: 7 & 12 months
7 & 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Local tolerance
Time Frame: ongoing to 12 months
ongoing to 12 months
Adverse events
Time Frame: ongoing to12 months
ongoing to12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Renovo

Collaborators

ICON Clinical Research

Investigators

  • Principal Investigator: Peter McCollum, MB MCh FRCS, Hull Royal Infirmary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

January 31, 2007

First Submitted That Met QC Criteria

January 31, 2007

First Posted (Estimate)

February 1, 2007

Study Record Updates

Last Update Posted (Estimate)

March 9, 2010

Last Update Submitted That Met QC Criteria

March 8, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RN1001-0042

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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