Venous UlcerPhase 2NCT00933348
Safety and Efficacy of the Fruit-based Product OPAL A for the Treatment of Chronic Venous and Pressure Ulcers
A Phase 2 study testing OPAL A in people with Venous Ulcer and Pressure Ulcer, run by Phoenix Eagle Company at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Ulcer, Pressure Ulcer
- What is being tested?
- OPAL A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteAustralia
- Study dates
- Jan 2010to Dec 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Austin Health, Aged Care Services, Medical and Cognitive Research Unit
Heidelberg West, Victoria, 3081
About this study
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.
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.
- Conditions
- Venous Ulcer, Pressure Ulcer
- Being tested
- OPAL A, Placebo
- Keywords
- ulcer, venous, pressure, wound, treatment
- Medical subject headings
- Varicose Ulcer, Pressure Ulcer, Ulcer, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPAL ADrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| OPAL A plus standard wound care | Active comparator | Not described Receives: Drug: OPAL A |
| Placebo plus standard wound care | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of adverse events
Measured: Weekly from Week -4 to Week 12
Physical examination findings and vital signs
Measured: 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).
Measured: Week -6, Day 0, Weeks 3, 6, 12
Secondary outcomes (8)
Time to 50% wound closure
Measured: Weekly from Weeks -6 to 12
Time to 100% wound closure
Measured: Weekly from Weeks -6 to 12
Proportion of participants with 50% or greater wound closure, or 100% wound closure at 12 weeks
Measured: Weekly from Weeks -6 to 12
Percentage change in wound surface area at 12 weeks
Measured: Weekly from Weeks -6 to 12
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)
Measured: Weekly from Week 0 to 12
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)
Measured: Day 0 and Weeks 6 and 12
Participant's and clinician/nurse overall satisfaction with treatment
Measured: Weeks 6 and 12
Use of health care resources/informal care
Measured: Day 0 and Weekly from Week 1 to 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2009 (estimated)
- Study startJan 2010
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Why it stopped: Slow recruitment caused rethink on the study design
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phoenix Eagle Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Woodward, FRACP, Principal investigator, Austin Health, Aged Care Services, Medical and Cognitive Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00933348
- Sponsor's protocol ID
- OPAL A-1001
- Status last verified
- Oct 2014
- First submitted
- 5 Jul 2009
- Last updated
- 30 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00933348
- Acronym / sponsor ID
- OPAL A-1001
- Conditions
- Venous Ulcer, Pressure Ulcer
- Keywords
- ulcer, venous, pressure, wound, treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Slow recruitment caused rethink on the study design
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Phoenix Eagle CompanyIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 7 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OPAL A plus standard wound care | Active comparator | Drug: OPAL A |
| Placebo plus standard wound care | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female.
- Aged ≥ 18 years.
- Presence of either:
- Able to tolerate compression therapy (for venous ulcer group only)
- Willing and able to provide written informed consent
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPAL AOPAL 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. | Drug | OPAL A plus standard wound care |
| PlaceboPlacebo 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. | Drug | Placebo plus standard wound care |
Primary outcome
Frequency and severity of adverse events
Time frame: Weekly from Week -4 to Week 12
Physical examination findings and vital signs
Time frame: 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).
Time frame: Week -6, Day 0, Weeks 3, 6, 12
8 secondary outcomes
Time to 50% wound closure
Time frame: Weekly from Weeks -6 to 12
Time to 100% wound closure
Time frame: Weekly from Weeks -6 to 12
Proportion of participants with 50% or greater wound closure, or 100% wound closure at 12 weeks
Time frame: Weekly from Weeks -6 to 12
Percentage change in wound surface area at 12 weeks
Time frame: Weekly from Weeks -6 to 12
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
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
Participant's and clinician/nurse overall satisfaction with treatment
Time frame: Weeks 6 and 12
Use of health care resources/informal care
Time frame: Day 0 and Weekly from Week 1 to 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Woodward, FRACP principal investigator
Austin Health, Aged Care Services, Medical and Cognitive Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OPAL A in people with Venous Ulcer and Pressure Ulcer, run by Phoenix Eagle Company at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 30 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and severity of adverse events (time frame: Weekly from Week -4 to Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2014.