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Trial registered on ANZCTR


Registration number
ACTRN12618000002280
Ethics application status
Approved
Date submitted
21/11/2017
Date registered
8/01/2018
Date last updated
29/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of using PROMOGRAN PRISMA® on leg ulcers that are slow to heal
Scientific title
Feasibility of using PROMOGRAN PRISMA® on stalled venous and stasis leg wounds
Secondary ID [1] 293408 0
Nil
Universal Trial Number (UTN)
U1111-1205-4567
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
venous leg ulcer 305559 0
Stasis leg ulcer 305560 0
Condition category
Condition code
Cardiovascular 304785 304785 0 0
Diseases of the vasculature and circulation including the lymphatic system
Skin 304800 304800 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Venous or stasis leg ulcers that are slow to healed (defined as having care meeting Standard of Care (appropriate wound bed preparation and compression therapy) for at least 4 weeks), and the wound size reduced by less than 30% over 4 weeks) will be treated with PROMOGRAN PRISMA®, a silver eluting cellulose/collagen matrix (ARTG # 197114), weekly for 6 weeks in conjunction with Standard of Care. PROMOGRAN PRISMA® matrix is a thin film in appearance. The matrix will be applied directly to the surface of the wounds, and will be cut to cover the entire wound surface area with the amount of matrix applied dependent on wound size. The matrix absorbs moisture from the wound and over time will be absorbed and does not require removal.
Patients will visit the wound clinic study sites on week 1 (first application of PROMOGRAN PRISMA®) 3, 5, 6 and week 12, and matrix will be applied by wound care nurses at the sites on week 1, 3 and 5. At week's 2 and 4 the usual care provider for the patient's wound will apply the matrix as part of standard dressing changes which include replenishing the primary dressing (PROMOGRAN PRISMA®) and secondary dressings (variable depending on clinical need) and associated compression. The usual care provider may be the patient, a carer/family member or community/facility/general practice nurse/or wound clinic nurse depending on individual circumstances. Instruction on how to apply the matrix at dressing changes will be provided verbally and written instructions provided along with matrix for the dressing change. At visits on week 3 and 5 patients will be asked if PROMOGRAN PRISMA® was reapplied as planned at week 2 and 4, and reasons for non-adherence recorded.
Intervention code [1] 299651 0
Treatment: Devices
Comparator / control treatment
No control group. Rate of wound healing will be compared to rate during 4 weeks prior to treatment with intervention.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304003 0
Feasibility of recruitment and study procedures determined from the number of patients recruited within four months and number of patients completing study by June 2018.
Timepoint [1] 304003 0
Four months (recruitment), to 30 June 2018 (completion)
Secondary outcome [1] 340700 0
Healed ‘study wound’ at 12 weeks (yes/no) defined as 100% epithelisation/wound closure as assessed by treating clinician
Timepoint [1] 340700 0
12 weeks
Secondary outcome [2] 340701 0
Change in perceived wound pain with time measured using visual analogue pain scale
Timepoint [2] 340701 0
Change from baseline over 12 weeks from 1st treatment with intervention
Secondary outcome [3] 340702 0
Change in % slough measured from images of wounds assessed by blinded reviewers
Timepoint [3] 340702 0
Change from baseline over 12 weeks from 1st treatment with intervention
Secondary outcome [4] 340703 0
Change in wound area with time measured from images of wounds assessed by blinded reviewers
Timepoint [4] 340703 0
Change from baseline over 12 weeks from 1st treatment with intervention
Secondary outcome [5] 340704 0
Change in ankle circumference measurements measured by treating clinician
Timepoint [5] 340704 0
Change from baseline over 12 weeks from 1st treatment with intervention
Secondary outcome [6] 340881 0
Change in calf circumference measured by treating clinician
Timepoint [6] 340881 0
Change from baseline over 12 weeks from 1st treatment with intervention
Secondary outcome [7] 340882 0
Days to wound healing of study wound, defined as 100% epithelisation/wound closure as assessed by treating clinician
Timepoint [7] 340882 0
Up to 12 weeks from first treatment with intervention

Eligibility
Key inclusion criteria
Male/female participants who are at least 18 years of age on the day of signing informed consent with chronic wounds treated at the study sites for four weeks after Standard of Care for the patient has been fully implemented.
• Have a venous or stasis leg ulcer that has reduced in size by less than 30% over the previous 4 weeks
• Do not have signs of clinical infection as defined by the International Wound Infection Institute (IWII) (Wound infection in clinical practice, 2016) as having the ‘presence of microbes in sufficient numbers or virulence to cause a host response locally or systemically’
• Are intending to continue to attend the study sites for wound care
• Are able to comply with study procedures including attending study sites for visits and following study procedures for dressing changes between study site visits
• Consent to wound images collected as part of Standard of Care for the four weeks prior to enrolment in the study being used to calculate pre-enrolment healing rate.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Known sensitivity to silver
• Known sensitivity to collagen
• Known sensitivity to Organic Regenerated Cellulose
• Unable to consent due to cognitive impairment or language limitations preventing understanding of provided information and hence capacity for informed consent.
• Uncontrolled systemic infection at time of recruitment as defined as the infection affecting the entire body with microorganisms spreading via the lymphatic and vascular systems in the body
• Patients with a life expectancy of less than six months in the opinion of the treating investigator
• Patients where the Care Objective for the wound is palliative with no expectation that the wound will heal
• Active vasculitis
• Full thickness burn injuries

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This study is a pilot to test recruitment and study procedure feasibility within a specific time frame with a convenience sample size of 5 participants selected to demonstrate feasibility. Given the sample size analysis of secondary endpoints will primarily use descriptive statistics as the study is not powered for efficacy.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/02/2018
Actual
7/02/2018
Date of last participant enrolment
Anticipated
7/04/2018
Actual
12/04/2018
Date of last data collection
Anticipated
30/06/2018
Actual
31/05/2018
Sample size
Target
5
Accrual to date
Final
4
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 9423 0
Mater Adult Hospital - South Brisbane
Recruitment postcode(s) [1] 18127 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 298033 0
Commercial sector/Industry
Name [1] 298033 0
Wound Management Pty Ltd
Country [1] 298033 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Wound Management Pty Ltd
Address
55 Little Edward St, Spring Hill, QLD 4000
PO Box 2375, Toowong DC, QLD 4000
Country
Australia
Secondary sponsor category [1] 297105 0
None
Name [1] 297105 0
Address [1] 297105 0
Country [1] 297105 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299061 0
Mater Misericordiae Ltd Human Research Ethics Committee (MML HREC)
Ethics committee address [1] 299061 0
Ethics committee country [1] 299061 0
Australia
Date submitted for ethics approval [1] 299061 0
06/11/2017
Approval date [1] 299061 0
30/11/2017
Ethics approval number [1] 299061 0
HREC/17/MHS/126

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

Contacts
Principal investigator
Name 79154 0
Dr John Bingley
Address 79154 0
Wound Innovations, 55 Little Edward St, Spring Hill, QLD 4000
Country 79154 0
Australia
Phone 79154 0
+61 7 3724 0100
Fax 79154 0
+61 7 3059 6030
Email 79154 0
John.Bingley@woundinnovations.com.au
Contact person for public queries
Name 79155 0
Kate Kruger
Address 79155 0
Wound Innovations, 55 Little Edward St, Spring Hill, QLD 4000
Country 79155 0
Australia
Phone 79155 0
+61 7 3724 0100
Fax 79155 0
Email 79155 0
kate.kruger@woundinnovations.com.au
Contact person for scientific queries
Name 79156 0
Kate Kruger
Address 79156 0
Wound Innovations, 55 Little Edward St, Spring Hill, QLD 4000
Country 79156 0
Australia
Phone 79156 0
+61 7 3724 0100
Fax 79156 0
Email 79156 0
kate.kruger@woundinnovations.com.au

No information has been provided regarding IPD availability


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.