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

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: Suspended
• Conditions: Pressure Ulcer; Venous Ulcer
• Intervention / Treatment: Drug: OPAL A; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Frequency and severity of adverse events	Weekly from Week -4 to Week 12
Physical examination findings and vital signs	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).	Week -6, Day 0, Weeks 3, 6, 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to 50% wound closure	Weekly from Weeks -6 to 12
Time to 100% wound closure	Weekly from Weeks -6 to 12
Proportion of participants with 50% or greater wound closure, or 100% wound closure at 12 weeks	Weekly from Weeks -6 to 12
Percentage change in wound surface area at 12 weeks	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)	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)	Day 0 and Weeks 6 and 12
Participant's and clinician/nurse overall satisfaction with treatment	Weeks 6 and 12
Use of health care resources/informal care	Day 0 and Weekly from Week 1 to 12

Collaborators and Investigators

• Sponsor: Phoenix Eagle Company
• Investigators: Principal Investigator: Michael Woodward, FRACP, Austin Health, Aged Care Services, Medical and Cognitive Research Unit

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: July 5, 2009
• First Submitted That Met QC Criteria: July 6, 2009
• First Posted (Estimate): July 7, 2009

Study Record Updates

• Last Update Posted (Estimate): October 30, 2014
• Last Update Submitted That Met QC Criteria: October 29, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: pressure; treatment; wound; venous; ulcer
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Leg Ulcer; Skin Ulcer; Varicose Veins; Ulcer; Varicose Ulcer; Pressure Ulcer
• Other Study ID Numbers: OPAL A-1001