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

Pressure Ulcer Clinical Trial

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.

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00933348
• Other study ID #: OPAL A-1001
• Status: Suspended
• Phase: Phase 2
• First received: July 5, 2009
• Last updated: October 29, 2014
• Start date: January 2010
• Est. completion date: December 2016

Study information

• Verified date: October 2014
• Source: Phoenix Eagle Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 30
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pressure Ulcer
• Ulcer
• Varicose Ulcer
• Venous Ulcer

Intervention

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
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.

Locations

Country	Name	City	State
Australia	Austin Health, Aged Care Services, Medical and Cognitive Research Unit	Heidelberg West	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Phoenix Eagle Company

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency and severity of adverse events		Weekly from Week -4 to Week 12	Yes
Primary	Physical examination findings and vital signs		Week -6, Day 0 and Weeks 6 and 12	Yes
Primary	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	Yes
Secondary	Time to 50% wound closure		Weekly from Weeks -6 to 12	No
Secondary	Time to 100% wound closure		Weekly from Weeks -6 to 12	No
Secondary	Proportion of participants with 50% or greater wound closure, or 100% wound closure at 12 weeks		Weekly from Weeks -6 to 12	No
Secondary	Percentage change in wound surface area at 12 weeks		Weekly from Weeks -6 to 12	No
Secondary	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	No
Secondary	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	No
Secondary	Participant's and clinician/nurse overall satisfaction with treatment		Weeks 6 and 12	No
Secondary	Use of health care resources/informal care		Day 0 and Weekly from Week 1 to 12	No