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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Venous Ulcer, Pressure Ulcer

Intervention / Treatment
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* Drug: OPAL A
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: OPAL A plus standard wound care<br> | Drug: OPAL A<br>* 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.<br>|
| Placebo Comparator: Placebo plus standard wound care<br> | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ulcer, venous, pressure, wound, treatment