Silver dressings and the diabetic foot

Phase 4

Completed

• Conditions: Diabetic foot ulcers; Metabolic and Endocrine - Diabetes; Skin - Other skin conditions

• Registration Number: ACTRN12614001234606
• Lead Sponsor: The Royal Melbourne Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-11-25
• Study Completion: 2019-07-18
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 176

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br><br>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).[12 weeks]

Secondary Outcome Measures

Name	Time	Method
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.<br><br>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.[12 weeks]