Healing chronic venous leg ulcers

Objectives

The principle objective of this research is to more precisely determine the effectiveness of hyperbaric oxygen therapy for healing chronic venous leg ulcers: A randomised, double-blind, placebo-controlled trial.

What is the purpose of the research?

The purpose of this research is to determine the effectiveness of hyperbaric oxygen treatment for people suffering from venous leg ulcers with regards to their wound healing, quality of life and cost-effectiveness.

Are you looking for people like me?

The research team is looking for people with a venous leg ulcer.  Potential participants will be assessed by the research team to determine if their leg ulcer fits the required criteria for inclusion in this study.

What will you ask me to do?

You will be asked to attend the Wesley Centre for Hyperbaric Medicine for a maximum of 16 weeks, as follows:

Weeks 1-4 – You will first have a screening assessment to check your eligibility to take part in the study. If you are eligible and agree to participate, you will then attend the wound care clinic once/week for 4 weeks.

After 4 weeks, your ulcer will be assessed to determine whether it has decreased in size by 50% or more.

Weeks 5-16  If your ulcer has decreased by at least ½ its size (over 50%)- You will continue to attend the wound care clinic once/week for standard wound care  (or until the ulcer has healed if this occurs earlier).

Weeks 5-16 Hyperbaric Chamber Treatment if your ulcer has NOT decreased by at least ½ its sizeYou will take part in the main hyperbaric chamber study requiring treatment in the chamber for 5 days/week for 6 weeks as well as once/week attendance at the wound care clinic (in the same building), plus a further 6 weeks attending the wound care clinic once/week or until the ulcer has healed (whichever comes first).

Are there any risks for me in taking part?

Hyperbaric treatment can have both beneficial and potentially adverse effects. People who have a higher chance of side effects from hyperbaric treatment will be excluded from the trial, but there is still a risk these side effects may happen. Potential side effects include:  ear/sinus discomfort or lung ventilation problems as a result of the pressure changes, confusion, dizziness, temporary visual changes and rarely, a 1 in 4000 risk of a seizure. Strategies are in place to manage these risks and full details will be provided if you choose to participate.  If you do agree to participate, you can withdraw from participation at any time during the project without comment or penalty.

Are there any benefits for me in taking part?

The potential benefit to you is that your leg ulcer may be healed or improved.  Another potential benefit is that if the results indicate that hyperbaric oxygen clearly improves healing, this treatment will be made available to other patients with similar problems. You will have played an important role in the advancement of scientific knowledge.

Will I be compensated for my time?

We would very much appreciate your participation in this research. To compensate you for your contribution, should you choose to participate, the research team will provide you with free wound treatment, bandages and reimburse your parking costs during your time in the study.

Who is funding this research?

The project is funded by the Wound Management Innovation Cooperative Research Centre, which is funded by the Australian Government Dept of Innovation, Industry, Science and Research.  The funding body will not have access to personally identifying information about you that may be obtained during the project.

I am interested – what should I do next?

If you would like to participate in this study, please contact the research team for details of the next step. You will be provided with further information to ensure that your decision and consent to participate is fully informed.

Research Team Contacts

Dr Andrew Ng, Medical Director, Wesley Centre for Hyperbaric Medicine.                               Phone: 07 3371 6033, Email: Andrew@wesleyhyperbaric.com.au

Please click here to download a pdf of our Prospective Patient Information Flyer.