Safety and Efficacy of the Fruit-Based Product OPAL A for the Treatment of Chronic Venous and Pressure Ulcers - Full Text View

Sponsored by:	Phoenix Eagle Company
Information provided by:	Phoenix Eagle Company
ClinicalTrials.gov Identifier:	NCT00933348

Purpose

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.

Condition	Intervention	Phase
Venous Ulcer	Drug: OPAL A	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Safety and Efficacy of the Fruit-Based Product OPAL A for the Treatment of Chronic Venous and Pressure Ulcers

Resource links provided by NLM:

MedlinePlus related topics: Pressure Sores

U.S. FDA Resources

Further study details as provided by Phoenix Eagle Company:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Time to 50% wound closure [ Time Frame: Weekly from Weeks -6 to 12 ] [ Designated as safety issue: No ]
Time to 100% wound closure [ Time Frame: Weekly from Weeks -6 to 12 ] [ Designated as safety issue: No ]
Proportion of participants with 50% or greater wound closure, or 100% wound closure at 12 weeks [ Time Frame: Weekly from Weeks -6 to 12 ] [ Designated as safety issue: No ]
Percentage change in wound surface area at 12 weeks [ Time Frame: Weekly from Weeks -6 to 12 ] [ Designated as safety issue: No ]
Participant's assessment of pain during wound dressing and wound pain in the 24 hours before each study visit (assessed using the McGill short-form pain survey) [ Time Frame: Weekly from Week 0 to 12 ] [ Designated as safety issue: No ]
Quality of life (QoL) scores and health state (for determination of quality-adjusted life years [QALYs]; assessed using the SF-12 health survey and the McGill short-form pain survey) [ Time Frame: Day 0 and Weeks 6 and 12 ] [ Designated as safety issue: No ]
Participant's and clinician/nurse overall satisfaction with treatment [ Time Frame: Weeks 6 and 12 ] [ Designated as safety issue: No ]
Use of health care resources/informal care [ Time Frame: Day 0 and Weekly from Week 1 to 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	September 2009
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
OPAL A plus standard wound care: Active Comparator	Drug: 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.
Standard wound care alone: No Intervention

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00933348

Contacts

Contact: Michael Woodward

+ 61 3 94962987

michael.woodward@austin.org.au

Locations

Australia, Victoria
Austin Health, Aged Care Services, Medical and Cognitive Research Unit
Heidelberg West, Victoria, Australia, 3081

Sponsors and Collaborators

Phoenix Eagle Company

Investigators

Principal Investigator:

Michael Woodward, FRACP

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

More Information

No publications provided

Responsible Party:	Phoenix Eagle Company Pty Ltd ( Mark Richardson )
Study ID Numbers:	OPAL A-1001
Study First Received:	July 5, 2009
Last Updated:	July 6, 2009
ClinicalTrials.gov Identifier:	NCT00933348 History of Changes
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Phoenix Eagle Company:

ulcer
venous
pressure
wound
treatment

Study placed in the following topic categories:

Varicose Ulcer
Varicose Veins
Skin Diseases
Ulcer

Vascular Diseases
Skin Ulcer
Pressure Ulcer
Leg Ulcer

Additional relevant MeSH terms:

Varicose Ulcer
Pathologic Processes
Varicose Veins
Skin Diseases
Ulcer

Vascular Diseases
Cardiovascular Diseases
Skin Ulcer
Pressure Ulcer
Leg Ulcer

ClinicalTrials.gov processed this record on September 10, 2009