Safety and Efficacy of the Fruit-based Product OPAL A for the Treatment of Chronic Venous and Pressure Ulcers

Inclusion Criteria: * Male or female. * Aged ≥ 18 years. * Presence of either: * a venous leg ulcer with a surface area ≥ 2 cm2 and \< 25 cm2 (best estimate of debrided wound), OR * a Stage II or III pressure ulcer (as per Australian Wound Management Association \[AWMA\] definitions) * Able to tolerate compression therapy (for venous ulcer group only) * Willing and able to provide written informed consent * Additional inclusion criterion after four-week standard care run-in period: * a less than or equal to 25% reduction in wound surface area compared with wound surface area at the screening visit Exclusion Criteria: * Another ulcer within 10 cm of the ulcer to be treated * Patients with diabetes (fasting blood glucose value ≥ 7 mmol/L or random blood glucose \> 11 mmol/L) that in the opinion of the investigator is uncontrolled * Ankle-brachial pressure index of \< 0.8 (participants with venous ulcers only) * Alanine transaminase (ALT) or aspartate transaminase (AST) levels 3X the upper limit of normal * Any dermatologic condition or disorder (with the exception of dermatitis associated with venous stasis) that may interfere with the appropriate assessment and treatment of the participant's ulcer * Clinical signs of ulcer infection. * Current or recent (within the past two weeks) daily treatment with immunosuppressive medications (including oral corticosteroids; inhaled and topical corticosteroids are permitted; topical agents must not be applied within 10 cm of ulcer wound), cytotoxins or anti-inflammatory agents (intermittent non-steroidal anti-inflammatory agent use is permitted) * Known hypersensitivity to paw paw products * Pregnancy, planned pregnancy or lactation * Participation in another clinical trial within one month of study entry * Another disease or condition that in the opinion of the investigator may jeopardize the safety of the participant or their ability to participate in the study * Participant previously screened or randomized in this study * Cognitive impairment that in the opinion of the investigator leaves the participant incapable of providing informed consent