Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001365550
Ethics application status
Approved
Date submitted
1/10/2024
Date registered
13/11/2024
Date last updated
13/11/2024
Date data sharing statement initially provided
13/11/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study testing a gel containing 0.1% mometasone furoate, applied once a day, to see if it helps in the treatment of chronic leg wounds
Scientific title
Effect of once-daily topical 0.1%w/w mometasone furoate hydrogel on wound size and pro-inflammatory mediators in adults with chronic wounds: a single-blind, randomised, placebo-controlled pilot study.
Secondary ID [1] 313009 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic leg wounds 335326 0
Condition category
Condition code
Skin 331899 331899 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
0.1% w/w mometasone furoate hydrogel applied once daily to the wound.
Dosage – 1 fingertip unit (0.5g) per 2% body surface area equivalent
Duration – 28 days, or until the wound has healed, whichever comes first
Adherence monitoring – Tubes will be measured prior to commencing trial, and at each timepoint, including final visit, to determine how much product has been used
Intervention code [1] 329644 0
Treatment: Drugs
Comparator / control treatment
Placebo hydrogel (hexylene glycol, purified water, cellulose K100M, citric acid)
Control group
Placebo

Outcomes
Primary outcome [1] 339516 0
Relative change from baseline in wound area
Timepoint [1] 339516 0
Baseline (day 0) and day 28 post-commencement of the intervention
Primary outcome [2] 339517 0
Relative change from baseline in the pro-inflammatory mediator MMP-8 in wound exudate
Timepoint [2] 339517 0
Baseline (day 0) and day 28 post-commencement of the intervention
Primary outcome [3] 339708 0
Relative change from baseline in the pro-inflammatory mediator TNF-alpha in wound exudate
Timepoint [3] 339708 0
Baseline (day 0) and day 28 post-commencement of the intervention
Secondary outcome [1] 440274 0
Relative change from baseline in wound area
Timepoint [1] 440274 0
Baseline (day 0) and days 7, 14, and 21 post-commencement of the intervention, and day 35 (7 days after cessation of the intervention)
Secondary outcome [2] 440275 0
Relative change from baseline in global score of patient-reported wound-related quality of life (wound QoL questionnaire)
Timepoint [2] 440275 0
Baseline (day 0) and days 7, 14, and 21 post-commencement of the intervention, and day 35 (7 days after cessation of the intervention)
Secondary outcome [3] 440276 0
Relative change from baseline in clinician reported wound characteristics - % of granulation
Timepoint [3] 440276 0
Baseline (day 0) and days 7, 14, and 21 post-commencement of the intervention, and day 35 (7 days after cessation of the intervention)
Secondary outcome [4] 440278 0
Relative change from baseline in the pro-inflammatory mediator MMP-8 in wound exudate.
Timepoint [4] 440278 0
Baseline (day 0) and day 14 post-commencement of the intervention
Secondary outcome [5] 440280 0
Amount of hydrogel used by participants
Timepoint [5] 440280 0
Baseline (day 0) and days 7, 14, 21 and 28 post-commencement of the intervention.
Secondary outcome [6] 440281 0
Safety endpoints
Timepoint [6] 440281 0
Throughout the course of the 35-day study period.
Secondary outcome [7] 440890 0
Relative change from baseline in the pro-inflammatory mediator TNF-alpha in wound exudate.
Timepoint [7] 440890 0
Baseline (day 0) and day 14 post-commencement of the intervention
Secondary outcome [8] 440891 0
Relative change from baseline in the pro-inflammatory mediator IL-1 beta in wound exudate.
Timepoint [8] 440891 0
Baseline (day 0) and day 14 post-commencement of the intervention
Secondary outcome [9] 440962 0
Relative change from baseline in the pro-inflammatory mediator IL-1 beta in wound exudate. This is an additional primary outcome.
Timepoint [9] 440962 0
Baseline (day 0) and day 28 post-commencement of the intervention
Secondary outcome [10] 441178 0
Relative change from baseline in clinician reported wound characteristics - % of epithelialisation
Timepoint [10] 441178 0
Baseline (day 0) and days 7, 14, and 21 post-commencement of the intervention, and day 35 (7 days after cessation of the intervention)
Secondary outcome [11] 441179 0
Relative change from baseline in clinician reported wound characteristics - % of slough
Timepoint [11] 441179 0
Baseline (day 0) and days 7, 14, and 21 post-commencement of the intervention, and day 35 (7 days after cessation of the intervention)
Secondary outcome [12] 441180 0
Relative change from baseline in clinician reported wound characteristics - % of necrosis
Timepoint [12] 441180 0
Baseline (day 0) and days 7, 14, and 21 post-commencement of the intervention, and day 35 (7 days after cessation of the intervention)

Eligibility
Key inclusion criteria
• Males or females aged 18 years and over.
• Subjects possessing a chronic lower limb wound which has not healed for at least one month with conventional treatments.
• Free of any dermatological or systemic disorder which could interfere with the results, at the discretion of the Investigator.
• Completed a preliminary medical history form.
• Have read, understood and signed an informed consent document relating to the specific type of study they are subscribing.
• Able to cooperate with the Investigator and research staff, willing to have the test materials applied according to the protocol and complete the full course of the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Individuals under 18 years of age. Diabetes, severe cardiac, respiratory, gastrointestinal, liver, renal disease, malignancy, or any other medical condition that may interfere with wound healing, at the discretion of the Investigator. Complications of these medical conditions may preclude individuals who are not well to meet the study requirements and attendance to the clinic.
• History of allergies or adverse reactions to the components of the specific products being tested.
• Use of other topical therapies in the week prior to or during participation in this trial.
• Individuals taking any medication (topical or systemic) such as antibiotics, NSAIDs, narcotics, corticosteroids, antineoplastics or immunosuppressants that may mask or interfere with the test results, at the discretion of the Investigator.
• A history of any acute or chronic disease that may interfere with or increase the risk of study participation.
• Excessive hair on the test sites.
• Individuals diagnosed with chronic skin allergies.
• Pregnant or nursing females.

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)
Randomised at central administration site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
16/03/2023
Date of last participant enrolment
Anticipated
10/04/2025
Actual
Date of last data collection
Anticipated
12/05/2025
Actual
Sample size
Target
20
Accrual to date
14
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27174 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment postcode(s) [1] 43256 0
3081 - Heidelberg West

Funding & Sponsors
Funding source category [1] 317448 0
Commercial sector/Industry
Name [1] 317448 0
Ego Pharmaceuticals
Country [1] 317448 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Ego Pharmaceuticals
Address
Country
Australia
Secondary sponsor category [1] 319738 0
None
Name [1] 319738 0
Address [1] 319738 0
Country [1] 319738 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316164 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 316164 0
Ethics committee country [1] 316164 0
Australia
Date submitted for ethics approval [1] 316164 0
24/03/2022
Approval date [1] 316164 0
31/08/2022
Ethics approval number [1] 316164 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136994 0
A/Prof Michael Woodward
Address 136994 0
Level 2, Centaur Building, Heidelberg Repatriation Hospital, 300 Waterdale Road, Ivanhoe, 3079, VIC
Country 136994 0
Australia
Phone 136994 0
+61 419 137 035
Fax 136994 0
Email 136994 0
michael.woodward@austin.org.au
Contact person for public queries
Name 136995 0
Nikki Frescos
Address 136995 0
Level 2, Centaur Building, Heidelberg Repatriation Hospital, 300 Waterdale Road, Ivanhoe, 3079, VIC
Country 136995 0
Australia
Phone 136995 0
+61 3 9496 2823
Fax 136995 0
Email 136995 0
mcru.recruitment@austin.org.au
Contact person for scientific queries
Name 136996 0
Nikki Frescos
Address 136996 0
Level 2, Centaur Building, Heidelberg Repatriation Hospital, 300 Waterdale Road, Ivanhoe, 3079, VIC
Country 136996 0
Australia
Phone 136996 0
+61 3 9496 2823
Fax 136996 0
Email 136996 0
mcru.recruitment@austin.org.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.