Pressure Ulcer, Venous Ulcer
Conditions
Keywords
ulcer, venous, pressure, wound, 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.
Interventions
DRUGOPAL 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.
DRUGPlacebo
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.
Sponsors
Phoenix Eagle Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| Time to 50% wound closure | Weekly from Weeks -6 to 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 |
| 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 |
| 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 |
Countries
Australia
Outcome results
None listed