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Trial registered on ANZCTR


Registration number
ACTRN12614001234606
Ethics application status
Approved
Date submitted
17/11/2014
Date registered
25/11/2014
Date last updated
6/04/2022
Date data sharing statement initially provided
10/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Silver dressings and the diabetic foot
Scientific title
Assessing the potential for silver dressings to enhance healing of diabetes-related foot ulcers.
Secondary ID [1] 285684 0
Nil
Universal Trial Number (UTN)
U1111-1164-1857
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic foot ulcers 293544 0
Condition category
Condition code
Metabolic and Endocrine 293819 293819 0 0
Diabetes
Skin 293867 293867 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A total of two hundred diabetic foot wounds will be randomised 1:1 to receive either (i) a silver impregnated wound dressing in combination with a foam dressing (Acticoat flex and Mepilex or Zetuvit) or (ii) similar silver free control dressing (Duoderm, Aquacel or Intrasite conformable with Mepilex or Zetuvit). The intervention is a topical wound dressing and will be changed twice per week. Treatment will continue until wound closure of maximum of 12 weeks. All other treatments will be equal between groups.
Intervention code [1] 290628 0
Treatment: Other
Comparator / control treatment
One hundred individuals with receive a silver free control dressing (Duoderm, Aquacel or Intrasite conformable with Mepilex or Zetuvit). The control dressing is a topical wound dressing and will be changed twice per week. Treatment will continue until wound closure of maximum of 12 weeks.All other treatments will be equal between groups.
Control group
Active

Outcomes
Primary outcome [1] 293604 0
The study aims to determine if a silver impregnated wound dressing leads to improvement in wound healing rate when compared to a similar silver free control dressing, when managing individuals with diabetes related foot ulcers.

Wound size will be determined by measuring the longest wound length and then the width of a line that runs perpendicular to longest length. Participants will be monitored for wound healing (time to complete healing and time for 50% wound reduction).
Timepoint [1] 293604 0
12 weeks
Secondary outcome [1] 311458 0
Participants wil be assessed for signs of wound infection and need and duration of antibiotic therapy, with a comparison being made between the cohort of individuals receiving a silver based dressing and those receiving a similar silver free dressing. This is a composite secondary outcome.

Infection will be defined as being present, for the purposes of this study, if there is evidence of (1) purulent discharge or (2) two or more of redness, pain/tenderness, swelling or warmth. The use of any antibiotics and their duration will be record for all subjects.
Timepoint [1] 311458 0
12 weeks

Eligibility
Key inclusion criteria
Participants will need to have a confirmed diagnosis of diabetes and an ulcer distal to the level of the ankle. The ulcer will be of less than 6 weeks duration at the time of recruitment and participants will be 18 years or older.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals who are pregnant, who have an allergy to silver, Mepilex or Zetuvit, wounds with tendons or underlying osteomyelitis and individuals with a life expectancy of less than 12 weeks will be excluded from the study.

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)
Consecutive individuals managed by the Diabetic Foot Unit / Podiatry Department at The Royal Melbourne Hospital, including the units inpatient and ambulatory care programs, will be invited to participate in this randomised study. Once an individual is identified as being suitable for participating in the study, a blinded researcher holding the allocation schedule with be contacted by phone in order to acquire the allocation to either receive treatmet with the silver dressing or non silver dressing.

All participants will receive standard care, including wound debridement, antibiotics in the setting of infection, revascularisation in the setting of peripheral arterial disease and maximisation of sugar control. The only variation to care will be the randomisation of participants to have wounds managed with a dressing that contains silver versus a similar dressing that is silver free.

As individuals may have more than one ulcer, affecting one or both feet, total numbers of wounds will be recruited for, rather than total number of individuals. It is planned that a total of 200 wounds will be recruited (with a maximum possible number of participants being 200). Wounds will be randomised 1:1 to receive either (i) a silver impregnated wound dressing in combination with a foam dressing (Acticoat flex and Mepilex or Zetuvit) or (ii) similar silver free control dressing (Duoderm, Aquacel or Intrasite conformable with Mepilex or Zetuvit). Recruited individuals will be randomised to receive one of the two dressing options for a total of 12 weeks, until they heal or the wound characteristics are such that these dressings can no longer be safely applied, whichever occurs first.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated randomisation process will be developed to randomised wounds 1:1 to receive either the silver dressing plan or non-silver dressing plan. However, as the presence of infection and peripheral arterial disease (PAD) are independent risk factors for non-healing, these factors will be controlled for during randomisation. Wounds will be assessed at recruitment and defined as being: no infection and no PAD, no infection with PAD, infection without PAD and infection with PAD. PAD will be defined as a toe pressure less than 60mmHg while the absence of PAD defined as a toe pressure equal or greater to 60mmHg. Infection will be defined as the presence of purulent discharge or 2 or more of redness, pain/tenderness, swelling, and warmth. Once recruited, a wound will be randomised to receive either the silver or non-silver based dressing, unless an identical wound type has already been recruited and randomised. In this situation, in order to ensure that equal numbers of wounds with the four different wound characteristics are equally randomised to receive silver and non-silver based dressings, the newly recruited wound will receive the opposite dressing type to that which has already been recruited.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a pilot study to assess the non-inferiority of non-silver dressings to achieve timely wound healing as compared to using a silver based wound dressing. At the end of the study, statistical analysis will be performed on the number of wounds achieving wound closure, the percentage closure from baseline of all wounds, and the number of wounds becoming infected and requiring antibiotics during the study period. Results will be analysed and compared between wounds receiving silver impregnated dressings as compared to those receiving standard silver free dressings. Analysis will also be made between wounds free of infection at baseline receiving the two treatment options as compared to infected wounds at baseline receiving the two treatment arms.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2014
Actual
4/12/2014
Date of last participant enrolment
Anticipated
31/12/2019
Actual
18/04/2019
Date of last data collection
Anticipated
Actual
18/07/2019
Sample size
Target
200
Accrual to date
Final
176
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3150 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 8928 0
3050 - Royal Melbourne Hospital

Funding & Sponsors
Funding source category [1] 290255 0
Hospital
Name [1] 290255 0
Diabetic Foot Unit
Country [1] 290255 0
Australia
Primary sponsor type
Hospital
Name
The Royal Melbourne Hospital
Address
The Royal Melbourne Hosptial
Grattan St
Parkville, Victoria
Australia, 3050
Country
Australia
Secondary sponsor category [1] 288962 0
None
Name [1] 288962 0
Address [1] 288962 0
Country [1] 288962 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291955 0
Melbourne Health
Ethics committee address [1] 291955 0
Ethics committee country [1] 291955 0
Australia
Date submitted for ethics approval [1] 291955 0
Approval date [1] 291955 0
27/10/2014
Ethics approval number [1] 291955 0
2014.089

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

Contacts
Principal investigator
Name 52838 0
A/Prof Paul Wraight
Address 52838 0
Department of Diabetes and Endocrinology
4 West
The Royal Melbourne Hospital
Grattan St
Parkville, Victoria, 3050
Country 52838 0
Australia
Phone 52838 0
+61409427943
Fax 52838 0
Email 52838 0
paul.wraight@mh.org.au
Contact person for public queries
Name 52839 0
Paul Wraight
Address 52839 0
Department of Diabetes and Endocrinology
4 West
The Royal Melbourne Hospital
Grattan St
Parkville, Victoria, 3050
Country 52839 0
Australia
Phone 52839 0
+61409427943
Fax 52839 0
Email 52839 0
paul.wraight@mh.org.au
Contact person for scientific queries
Name 52840 0
Paul Wraight
Address 52840 0
Department of Diabetes and Endocrinology
4 West
The Royal Melbourne Hospital
Grattan St
Parkville, Victoria, 3050
Country 52840 0
Australia
Phone 52840 0
+61409427943
Fax 52840 0
Email 52840 0
paul.wraight@mh.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
Confidential data


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
SourceTitleYear of PublicationDOI
EmbaseProspective randomised placebo-controlled trial assessing the efficacy of silver dressings to enhance healing of acute diabetes-related foot ulcers.2023https://dx.doi.org/10.1007/s00125-022-05855-7
N.B. These documents automatically identified may not have been verified by the study sponsor.