Clinical trial NCT00933348: 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
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Venous Ulcer
Pressure Ulcer
Keywords: ulcer
venous
pressure
wound
treatment
Lead sponsor: Phoenix Eagle Company
Sponsor class: INDUSTRY
First posted: 2009-07-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Frequency and severity of adverse events
timeFrame: Weekly from Week -4 to Week 12
measure: Physical examination findings and vital signs
timeFrame: Week -6, Day 0 and Weeks 6 and 12
measure: Clinical laboratory assessments (full blood count [FBC], blood chemistry, liver function tests and coagulation parameters) as changed from Day 0 (i.e., baseline/randomization).
timeFrame: Week -6, Day 0, Weeks 3, 6, 12
Secondary outcomes:
measure: Time to 50% wound closure
timeFrame: Weekly from Weeks -6 to 12
measure: Time to 100% wound closure
timeFrame: Weekly from Weeks -6 to 12
measure: Proportion of participants with 50% or greater wound closure, or 100% wound closure at 12 weeks
timeFrame: Weekly from Weeks -6 to 12
measure: Percentage change in wound surface area at 12 weeks
timeFrame: Weekly from Weeks -6 to 12
measure: 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)
timeFrame: Weekly from Week 0 to 12
measure: 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)
timeFrame: Day 0 and Weeks 6 and 12
measure: Participant's and clinician/nurse overall satisfaction with treatment
timeFrame: Weeks 6 and 12
measure: Use of health care resources/informal care
timeFrame: Day 0 and Weekly from Week 1 to 12
Other outcomes:
Locations:
city: Heidelberg West
country: Australia
facility: Austin Health, Aged Care Services, Medical and Cognitive Research Unit
state: Victoria
Study officials:
affiliation: Austin Health, Aged Care Services, Medical and Cognitive Research Unit
name: Michael Woodward, FRACP
role: PRINCIPAL_INVESTIGATOR
References: