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

NCT00933348 | Suspended Phase 2

• 1 other identifier: OPAL A-1001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Ulcer; Pressure Ulcer

Keywords

ulcer; venous; pressure; wound; treatment

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• 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

Study Arms (2)

OPAL A plus standard wound care

ACTIVE COMPARATOR

Drug: OPAL A

Placebo plus standard wound care

PLACEBO COMPARATOR

Drug: Placebo

Interventions

OPAL A DRUG

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.

OPAL A plus standard wound care

Placebo DRUG

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.

Placebo plus standard wound care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• a less than or equal to 25% reduction in wound surface area compared with wound surface area at the screening visit

You may not qualify if:

• 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

Sponsors & Collaborators

• Phoenix Eagle Company: lead

Study Sites (1)

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

Heidelberg West, Victoria, 3081, Australia

Location

MeSH Terms

Conditions

Varicose Ulcer; Pressure Ulcer; Ulcer; Wounds and Injuries

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Woodward, FRACP

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2009
• First Posted: July 7, 2009
• Study Start: January 1, 2010
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 30, 2014

Record last verified: 2014-10

Locations

AU (1)