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

Primary Purpose

Venous Ulcer, Pressure Ulcer

Status

Suspended

Phase

Phase 2

Locations

Australia

Study Type

Interventional

Intervention

OPAL A

Placebo

About this trial

This is an interventional treatment trial for Venous Ulcer focused on measuring ulcer, venous, pressure, wound, treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

OPAL A plus standard wound care

Placebo plus standard wound care

Arm Description

Outcomes

Primary Outcome Measures

Frequency and severity of adverse events

Physical examination findings and vital signs

Clinical laboratory assessments (full blood count [FBC], blood chemistry, liver function tests and coagulation parameters) as changed from Day 0 (i.e., baseline/randomization).

Secondary Outcome Measures

Time to 50% wound closure

Time to 100% wound closure

Proportion of participants with 50% or greater wound closure, or 100% wound closure at 12 weeks

Percentage change in wound surface area at 12 weeks

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)

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)

Participant's and clinician/nurse overall satisfaction with treatment

Use of health care resources/informal care

Full Information

NCT ID

NCT00933348

First Posted

July 5, 2009

Last Updated

October 29, 2014

Sponsor

Phoenix Eagle Company

1. Study Identification

Unique Protocol Identification Number

NCT00933348

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Suspended

Why Stopped

Slow recruitment caused rethink on the study design

Study Start Date

January 2010 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Phoenix Eagle Company

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Venous Ulcer, Pressure Ulcer

Keywords

ulcer, venous, pressure, wound, treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

OPAL A plus standard wound care

Arm Type

Active Comparator

Arm Title

Placebo plus standard wound care

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

OPAL A

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

Frequency and severity of adverse events

Time Frame

Weekly from Week -4 to Week 12

Title

Physical examination findings and vital signs

Time Frame

Week -6, Day 0 and Weeks 6 and 12

Title

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

Secondary Outcome Measure Information:

Title

Time to 50% wound closure

Time Frame

Weekly from Weeks -6 to 12

Title

Time to 100% wound closure

Time Frame

Weekly from Weeks -6 to 12

Title

Proportion of participants with 50% or greater wound closure, or 100% wound closure at 12 weeks

Time Frame

Weekly from Weeks -6 to 12

Title

Percentage change in wound surface area at 12 weeks

Time Frame

Weekly from Weeks -6 to 12

Title

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

Title

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

Title

Participant's and clinician/nurse overall satisfaction with treatment

Time Frame

Weeks 6 and 12

Title

Use of health care resources/informal care

Time Frame

Day 0 and Weekly from Week 1 to 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Woodward, FRACP

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Heidelberg West

State/Province

Victoria

ZIP/Postal Code

3081

Country

Australia

12. IPD Sharing Statement

Learn more about this trial

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

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