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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00933348




Registration number
NCT00933348
Ethics application status
Date submitted
5/07/2009
Date registered
7/07/2009
Date last updated
30/10/2014

Titles & IDs
Public title
Safety and Efficacy of the Fruit-based Product OPAL A for the Treatment of Chronic Venous and Pressure Ulcers
Scientific 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.
Secondary ID [1] 0 0
OPAL A-1001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Ulcer 0 0
Pressure Ulcer 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Skin 0 0 0 0
Other skin conditions
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - OPAL A
Treatment: Drugs - Placebo

Active comparator: OPAL A plus standard wound care -

Placebo comparator: Placebo plus standard wound care -


Treatment: Drugs: 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.

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Frequency and severity of adverse events
Timepoint [1] 0 0
Weekly from Week -4 to Week 12
Primary outcome [2] 0 0
Physical examination findings and vital signs
Timepoint [2] 0 0
Week -6, Day 0 and Weeks 6 and 12
Primary outcome [3] 0 0
Clinical laboratory assessments (full blood count [FBC], blood chemistry, liver function tests and coagulation parameters) as changed from Day 0 (i.e., baseline/randomization).
Timepoint [3] 0 0
Week -6, Day 0, Weeks 3, 6, 12
Secondary outcome [1] 0 0
Time to 50% wound closure
Timepoint [1] 0 0
Weekly from Weeks -6 to 12
Secondary outcome [2] 0 0
Time to 100% wound closure
Timepoint [2] 0 0
Weekly from Weeks -6 to 12
Secondary outcome [3] 0 0
Proportion of participants with 50% or greater wound closure, or 100% wound closure at 12 weeks
Timepoint [3] 0 0
Weekly from Weeks -6 to 12
Secondary outcome [4] 0 0
Percentage change in wound surface area at 12 weeks
Timepoint [4] 0 0
Weekly from Weeks -6 to 12
Secondary outcome [5] 0 0
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)
Timepoint [5] 0 0
Weekly from Week 0 to 12
Secondary outcome [6] 0 0
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)
Timepoint [6] 0 0
Day 0 and Weeks 6 and 12
Secondary outcome [7] 0 0
Participant's and clinician/nurse overall satisfaction with treatment
Timepoint [7] 0 0
Weeks 6 and 12
Secondary outcome [8] 0 0
Use of health care resources/informal care
Timepoint [8] 0 0
Day 0 and Weekly from Week 1 to 12

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Suspended
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2016
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Health, Aged Care Services, Medical and Cognitive Research Unit - Heidelberg West
Recruitment postcode(s) [1] 0 0
3081 - Heidelberg West

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Phoenix Eagle Company
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00933348
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Woodward, FRACP
Address 0 0
Austin Health, Aged Care Services, Medical and Cognitive Research Unit
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00933348