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

• Status: Suspended
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to examine the safety and efficacy of the fruit-based product OPAL A for the treatment of chronic venous and pressure ulcers.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Phoenix Eagle Company

Criteria

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