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

NCT ID: NCT00933348

Last Updated: 2014-10-30

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2016-12-31

Brief 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.

Conditions

Venous Ulcer; Pressure Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

OPAL A plus standard wound care

Group Type: ACTIVE_COMPARATOR

OPAL A

Intervention Type: DRUG

OPAL A will be supplied in two formulations: as a Filtrate (0.5 mL per cm2 of ulcer area, applied into the ulcer cavity) and as a Cream (about 1 to 5 g applied as a thin smear on surrounding skin). Both formulations will be applied daily. However, if the ulcer begins to hypergranulate, the OPAL A Filtrate will only be administered once every 72 hours.

Placebo plus standard wound care

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo will be supplied in two formulations: as a Filtrate (0.5 mL per cm2 of ulcer area, applied into the ulcer cavity) and as a Cream (about 1 to 5 g applied as a thin smear on surrounding skin). Both formulations will be applied daily. However, if the ulcer begins to hypergranulate, the Placebo Filtrate will only be administered once every 72 hours.

Interventions

OPAL A

OPAL A will be supplied in two formulations: as a Filtrate (0.5 mL per cm2 of ulcer area, applied into the ulcer cavity) and as a Cream (about 1 to 5 g applied as a thin smear on surrounding skin). Both formulations will be applied daily. However, if the ulcer begins to hypergranulate, the OPAL A Filtrate will only be administered once every 72 hours.

Intervention Type: DRUG

Placebo

Placebo will be supplied in two formulations: as a Filtrate (0.5 mL per cm2 of ulcer area, applied into the ulcer cavity) and as a Cream (about 1 to 5 g applied as a thin smear on surrounding skin). Both formulations will be applied daily. However, if the ulcer begins to hypergranulate, the Placebo Filtrate will only be administered once every 72 hours.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Phoenix Eagle Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Woodward, FRACP

Role: PRINCIPAL_INVESTIGATOR

Austin Health, Aged Care Services, Medical and Cognitive Research Unit

Locations

Austin Health, Aged Care Services, Medical and Cognitive Research Unit

Heidelberg West, Victoria, Australia

Countries

Australia

Other Identifiers

OPAL A-1001

Identifier Type: -

Identifier Source: org_study_id