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

October 29, 2014 updated by: Phoenix Eagle Company

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Frequency and severity of adverse events
Time Frame: Weekly from Week -4 to Week 12
Weekly from Week -4 to Week 12
Physical examination findings and vital signs
Time Frame: Week -6, Day 0 and Weeks 6 and 12
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
Week -6, Day 0, Weeks 3, 6, 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Time to 50% wound closure
Time Frame: Weekly from Weeks -6 to 12
Weekly from Weeks -6 to 12
Time to 100% wound closure
Time Frame: Weekly from Weeks -6 to 12
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
Weekly from Weeks -6 to 12
Percentage change in wound surface area at 12 weeks
Time Frame: Weekly from Weeks -6 to 12
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
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
Day 0 and Weeks 6 and 12
Participant's and clinician/nurse overall satisfaction with treatment
Time Frame: Weeks 6 and 12
Weeks 6 and 12
Use of health care resources/informal care
Time Frame: Day 0 and Weekly from Week 1 to 12
Day 0 and Weekly from Week 1 to 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Phoenix Eagle Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael Woodward, FRACP, Austin Health, Aged Care Services, Medical and Cognitive Research Unit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2010

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 30, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OPAL A-1001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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