Safety and Efficacy of the Fruit-based Product OPAL A for... | NCT00933348

NCT00933348

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Label	Type	Description	Intervention Names
OPAL A plus standard wound care	Active Comparator		Drug: OPAL A
Placebo plus standard wound care	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OPAL A	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency and severity of adverse events		Weekly from Week -4 to Week 12
Physical examination findings and vital signs		Week -6, Day 0 and Weeks 6 and 12
Clinical laboratory assessments (full blood count [FBC], blood chemistry, liver function tests and coagulation parameters) as changed from Day 0 (i.e., baseline/randomization).		Week -6, Day 0, Weeks 3, 6, 12

Secondary Outcomes

Measure	Description	Time Frame
Time to 50% wound closure		Weekly from Weeks -6 to 12
Time to 100% wound closure		Weekly from Weeks -6 to 12
Proportion of participants with 50% or greater wound closure, or 100% wound closure at 12 weeks

Eligibility Module

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