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

Phoenix Eagle Company

Status and phase

Suspended

Phase 2

Conditions

Venous Ulcer

Pressure Ulcer

Treatments

Drug: OPAL A

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00933348

OPAL A-1001

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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