Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001229763
Ethics application status
Approved
Date submitted
19/08/2022
Date registered
12/09/2022
Date last updated
12/09/2022
Date data sharing statement initially provided
12/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomized clinical trial assessing efficacy of a novel Moisturising Skin Support versus standard care for management of chronic wounds
Scientific title
Randomized clinical trial assessing efficacy of a novel Moisturising Skin Support versus standard care for management of chronic wounds in adult patients
Secondary ID [1] 307815 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Wounds 327407 0
Condition category
Condition code
Infection 324537 324537 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interventional study of a novel moisturising skin support versus standard care. The treatment is provided as an alternative wound care treatment to the standard chronic wound care currently being applied in wound care clinics. The Application of treatment in performed by wound care nurses at time of bandage change, usually 7-19 days apart, for a period of up to 3 years, at the medical centre.
The treatment is a topical (cream product) that also has a sorbolene base cream.
The investigational product is a combination of two novel active proprietary ingredients in a cream; at 5% Papaya and 2% Palmidrol (both are on the TGA permitted ingredients list) as well as sorbolene.
The intervention (cream) is applied at a clinic appointment so the process for monitoring adherence to the intervention is performed at each bandage change by the wound care nurses.

Intervention code [1] 324283 0
Treatment: Other
Comparator / control treatment
Standard treatment; water based sorbolene cream.
Control group
Active

Outcomes
Primary outcome [1] 332361 0
Change in wound size assessed by clinical review undertaken by wound care nurses at each dressing change;
Timepoint [1] 332361 0
Baseline and every dressing change (7-10 days) while enrolled in the study, for a maximum of 3 years.
Primary outcome [2] 332401 0
Presence of infection assessed by clinical review undertaken by wound care nurses at each dressing change
Timepoint [2] 332401 0
Baseline and every dressing change (7-10 days) while enrolled in the study, for a maximum of 3 years.
Secondary outcome [1] 413193 0
Change in inflammation assessed by nurse review of photographs taken at each dressing change.
Timepoint [1] 413193 0
Baseline and every dressing change (7-10 days) while enrolled in the study, for a maximum of 3 years.
Secondary outcome [2] 413341 0
Change in wound pain assessed by a 1-10 Visual Analogue Scale.
Timepoint [2] 413341 0
Baseline and every dressing change (7-10 days) while enrolled in the study, for a maximum of 3 years.

Eligibility
Key inclusion criteria
To be eligible for inclusion, the participant must fulfill the following criteria:
• Written informed consent
• Stated availability for attending the pharmacy for regular dressing changes as required (for up to 3 years; or to healed).
• Provided permission for photographs of the wound (no other identifying information in the photograph) and wound assessment by the wound nurse at the time of the change of dressing, and completion of a daily record diary (between changes in dressings)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The presence of any of the following criteria will exclude the participant from participating in the study:
Any clinically relevant abnormal findings which, in the opinion of the pharmacists and general practitioners that may put the participant at risk of adverse events because of participation in the clinical trial

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered containers that are identical, except for the number on the containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The purpose of this study is to explore the overall evaluation of efficacy of study test products in the target populations. The application of a mixed-model approach considering covariables (age, sex, wound characteristics such as size and depth at start of therapy) will be used in analysis for assessment of change. All data in this study will be captured and assessed using MS Office (Word or Excel) formats and statistical packages such as SPSS, STRATA and PRISM.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/10/2022
Actual
Date of last participant enrolment
Anticipated
2/06/2025
Actual
Date of last data collection
Anticipated
22/11/2027
Actual
Sample size
Target
528
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,TAS
Recruitment postcode(s) [1] 38332 0
4715 - Biloela
Recruitment postcode(s) [2] 38333 0
7000 - Hobart

Funding & Sponsors
Funding source category [1] 312084 0
Commercial sector/Industry
Name [1] 312084 0
Health Focus Products Australia Pty. Ltd.
Country [1] 312084 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Optiderma Biosciences Pty. Ltd
Address
71 Bathurst Street, Hobart, Tasmania 7000, Australia
Country
Australia
Secondary sponsor category [1] 313604 0
None
Name [1] 313604 0
Address [1] 313604 0
Country [1] 313604 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311492 0
National Institute of Integrative Medicine Human Research Ethics Committee
Ethics committee address [1] 311492 0
21 Burwood Rd, Hawthorn VIC 3122
Ethics committee country [1] 311492 0
Australia
Date submitted for ethics approval [1] 311492 0
18/01/2022
Approval date [1] 311492 0
02/05/2022
Ethics approval number [1] 311492 0
0098E_2022

Summary
Brief summary
The aim of the clinical trial is to determine if the novel Moisturising Skin Support is as effective or more effective in managing chronic wounds than standard care (sorbolene cream) when used by wound care nurses within the pharmacy setting over a 3 year period. The hypothesis is that the novel moisturising skin support will be as more effective than standard treatment in managing chronic wounds,
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121290 0
Dr Mark Baldock
Address 121290 0
Bathurst St. Medical Centre and Pharmacy, 71 Bathurst Street, Hobart, Tasmania 7000, Australia
Country 121290 0
Australia
Phone 121290 0
+61 409792646
Fax 121290 0
Email 121290 0
drmark.baldock@gmail.com
Contact person for public queries
Name 121291 0
Dr Elizabeth Steels
Address 121291 0
Evidence Sciences Pty. Ltd.
Unit 2 / 884 Brunswick Street New Farm, Brisbane 4005 QLD Australia
Country 121291 0
Australia
Phone 121291 0
+61431003929
Fax 121291 0
Email 121291 0
drbeth@evidencesciences.com.au
Contact person for scientific queries
Name 121292 0
Dr Elizabeth Steels
Address 121292 0
Evidence Sciences Pty. Ltd.
Unit 2 / 884 Brunswick Street New Farm, Brisbane 4005 QLD Australia
Country 121292 0
Australia
Phone 121292 0
+61431003929
Fax 121292 0
Email 121292 0
drbeth@evidencesciences.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.