Clinical Trial of OPAL A

Following the remarkable observations of OPAL A and OPAL001 in the treatment of ulcers and burns, Phoenix Eagle has commenced a proof-of-concept clinical trial.

The trial will examine the safety and efficacy of OPAL A Filtrate and Cream on “hard-to-heal” venous and pressure ulcers. Associate Professor Michael Woodward, head of Aged Care at Austin Health in Melbourne and immediate-past president of the Australian Wound Management Association, is the principal investigator.

The trial commenced in January 2010 at the Heidelberg Repatriation Hospital, one of three hospitals comprising Austin Health in Melbourne, and is expected to be completed in 18 months. The actual date of completion will depend on the recruitment rate and the percentage of recruits who pass into the trial proper from an initial screening stage lasting up to 4 weeks. It 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 will ensure that only truly hard-to-heal ulcers will be admitted to the second stage of the trial; any subject that shows significant improvement in the screening stage will be excluded. The second stage (trial proper) will last 12 weeks or until closure of the ulcer, whichever comes first, with 30 persons being recruited for the second stage of the trial.