Status:
SUSPENDED
Safety and Efficacy of the Fruit-based Product OPAL A for the Treatment of Chronic Venous and Pressure Ulcers
Lead Sponsor:
Phoenix Eagle Company
Conditions:
Venous Ulcer
Pressure Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00933348
Start Date
January 1 2010
End Date
December 1 2016
Last Update
October 30 2014
Active Locations (1)
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1
Austin Health, Aged Care Services, Medical and Cognitive Research Unit
Heidelberg West, Victoria, Australia, 3081