We have a large number of clinical case histories attesting to the therapeutic and cosmetic properties of the OPAL Products and in particular OPAL A.
Soon after the formation of the Company we decided to focus the research on OPAL A and its effect on dermal ulcers of all aetiologies, as a result of a number of remarkable results from the use of OPAL A on pressure and diabetic foot ulcers.
- A clinical trial was conducted at the Quadriplegic Centre in Shenton Park, Perth, Western Australia between November 2003 and June 2004. All of the patients that were treated showed noticeable improvement to what had been non-healing ulcers.
- A number of reports on the outcomes from treatment of dermal ulcers and burns have been written by medical researchers and clinicians and several papers have been published in Wound Practice & Research, the journal of the Australian Wound Management Association.
- Professor Geoffrey Mitchell, head of Research in the School of Medicine at The University of Queensland, has written a number of reports, conference presentations and published papers on the clinical effects of OPAL A. He has received approval from the Therapeutic Goods Administration to use OPAL A as an unapproved therapeutic good for the treatment of non-healing venous and pressure ulcers under the Approved Prescriber Scheme. He has had positive results in all the patients that he has treated to date.
- Associate Professor Michael Woodward of the University of Melbourne and head of the Wound Clinic at the Heidelberg Repatriation Hospital was also recently granted approval to use OPAL A under the Approved Prescriber Scheme.
In January 2010 a proof-of-concept clinical trial to investigate the safety and efficacy of OPAL A in the treatment of venous and pressure ulcers was commenced at the Heidelberg Repatriation Hospital in Melbourne. Associate Professor Michael Woodward is the principal investigator. The trial is a randomised, single-blind, placebo-controlled trial, with the placebo consisting of a filtrate and cream derived from pawpaw that has not been subjected to the OPAL Process. Screening in a 4-week Run-in Stage will ensure that only truly hard-to-heal ulcers will be admitted to the Randomised Stage of the trial; any subject that shows significant improvement in the Run-in Stage will be excluded.
This trial was temporarily halted at the end of 2010 due to a lack of funding, partly caused by the majority of trial subjects responding well to best-practice treatment in the Run-in Stage and thereby being screened out of the Randomised Stage. The preliminary results of the trial were released in a poster presentation at the biennial Australian Wound Management Association conference at the Gold Coast in May 2014
It is intended to re-commence the trial at the start of 2015. In an unsuccessful NHMRC application in 2013 one of the two assessors noted:
- This is a well-designed and thorough study, which is logical in the approach that is being taken. If successful, it will be well received both nationally and internationally, particularly since the trial is designed in line with FDA recommendations. Given the preliminary clinical results, this study is likely to demonstrate proof of principle that the use of OPAL A is beneficial in treating ulcers
It is planned to submit a further NHMRC grant application in 2015.
- A clinical trial on chronic ulcers of varying aetiologies was completed at The Royal Hobart Hospital in 2012. Professor Sankar Sinha, Associate Professor of Surgery at the University of Tasmania, was the principal investigator. The trial design and its results have been written up as a manuscript and are to be submitted for publication in Wound Practice & Research.