None listed
Conditions
Brief summary
To determine if a silver impregnated wound dressing has any clinical benefit over using a similar silver free control dressing, when managing individuals with diabetes-related foot ulcers. Wound healing rates, signs of infection, and need and duration of antibiotic therapy will be compared between the cohort of individuals receiving a silver based dressing and those receiving a similar silver free dressing. Outcomes will also be assessed regarding any clinical benefit in using a silver impregnated wound dressing as compared to a similar silver free control dressing on wounds that are both (1) clinically infected (purulent discharge or 2 or more of redness, pain/tenderness, swelling, warmth) at the outset as well as (2) those that have no signs of infection.
Interventions
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
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.
Sponsors
The Royal Melbourne Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed