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

Phase 2

Suspended

• Conditions: Venous Ulcer; Pressure Ulcer
• Interventions: Drug: OPAL A; Drug: Placebo

• Registration Number: NCT00933348
• Lead Sponsor: Phoenix Eagle Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-05
• Study First Submitted QC: 2009-07-06
• Study First Posted: 2009-07-07
• Study Start: 2010-01
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-29
• Last Update Posted: 2014-10-30
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OPAL A plus standard wound care	OPAL A	-
Placebo plus standard wound care	Placebo	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Austin Health, Aged Care Services, Medical and Cognitive Research Unit; 🇦🇺 Heidelberg West, Victoria, Australia