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

Sponsor:	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 Pressure Ulcer	Drug: OPAL A Drug: Placebo	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomised, Double-blind, Placebo-controlled Study of the 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:	January 2010
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: OPAL A plus standard wound care	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.
Placebo Comparator: Placebo plus standard wound care	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.

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
Cognitive impairment that in the opinion of the investigator leaves the participant incapable of providing informed consent

Contacts and Locations

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

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:	Mark Richardson, Phoenix Eagle Company Pty Ltd
ClinicalTrials.gov Identifier:	NCT00933348 History of Changes
Other Study ID Numbers:	OPAL A-1001
Study First Received:	July 5, 2009
Last Updated:	June 29, 2011
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Phoenix Eagle Company:

ulcer
venous
pressure
wound
treatment

Additional relevant MeSH terms:

Pressure Ulcer
Ulcer
Varicose Ulcer
Skin Ulcer
Skin Diseases

Pathologic Processes
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer

ClinicalTrials.gov processed this record on February 09, 2012