To undertake a systematic review of the diagnostic performance of clinical examination, sample acquisition and sample analysis in infected foot ulcers in diabetes.Nineteen electronic databases plus other sources were searched. To be included, studies had to fulfil the following criteria: (i) compare a method of clinical assessment, sample collection or sample analysis with a reference standard; (ii) recruit diabetic individuals with foot ulcers; (ii) present 2 x 2 diagnostic data. Studies were critically appraised using a 12-item checklist.Three eligible studies were identified, one each on clinical examination, sample collection and sample analysis. For all three, study groups were heterogeneous with respect to wound type and a small proportion of participants had foot ulcers due to diabetes. No studies identified an optimum reference standard. Other methodological problems included non-blind interpretation of tests and the time lag between index and reference tests. Individual signs or symptoms of infection did not prove to be useful tests when assessed against punch biopsy as the reference standard. The wound swab did not perform well when assessed against tissue biopsy. Semiquantitative analysis of wound swab might be a useful alternative to quantitative analysis. The limitations of these findings and their impact on recommendations from relevant clinical guidelines are discussed.Given the importance of this topic, it is surprising that only three eligible studies were identified. It was not possible to describe the optimal methods of diagnosing infection in diabetic patients with foot ulceration from the evidence identified in this systematic review.
Background Venous leg ulcers are a type of chronic wound affecting up to 1% of adults in developed countries at some point during their lives. Many of these wounds are colonised by bacteria or show signs of clinical infection. The presence of infection may delay ulcer healing. There are two main strategies used to prevent and treat clinical infection in venous leg ulcers: systemic antibiotics and topical antibiotics or antiseptics. Objectives The objective of the review is to determine the effects of systemic antibiotics, topical antibiotics and antiseptics on the healing of venous ulcers. Search methods For the update of this review we searched the Cochrane Wounds Group Specialised Register (searched 24/09/09); The Cochrane Central Register of Controlled Trials (CENTRAL) ‐ The Cochrane Library 2009 Issue 3; Ovid MEDLINE ‐ 1950 to September Week 3 2009; Ovid EMBASE ‐ 1980 to 2009 Week 38; and EBSCO CINAHL ‐ 1982 to September Week 3 2009. No language or publication date restrictions were applied. Selection criteria Randomised controlled trials recruiting people with venous leg ulceration and evaluating at least one systemic antibiotic, topical antibiotic or topical antiseptic that reported an objective assessment of wound healing (e.g. time to complete healing, frequency of complete healing, change in ulcer surface area) were eligible for inclusion. Selection decisions were made by two authors working independently. Data collection and analysis Information on the characteristics of participants, interventions and outcomes were recorded on a standardised data extraction form. In addition, aspects of trial methods were extracted, including randomisation, allocation concealment, blinding of participants and outcome assessors, incomplete outcome data and study group comparability at baseline. Data extraction and validity assessment were conducted by one author and checked by a second. Main results Twenty five trials reporting 32 comparisons were identified. Five trials evaluated systemic antibiotics; the remainder evaluated topical preparations: cadexomer iodine (10 trials); povidone iodine (5 trials); peroxide‐based preparations (3 trials); ethacridine lactate (1 trial); mupirocin (1 trial); and chlorhexidine (1 trial). For the systemic antibiotics, the only comparison where a statistically significant between‐group difference was detected was that in favour of the antihelminthic levamisole when compared with placebo. This trial, in common with the other evaluations of systemic antibiotics, was small and so the observed effect could have occurred by chance or been due to baseline imbalances in prognostic factors. For topical preparations, there is some evidence to suggest that cadexomer iodine generates higher healing rates than standard care. One study showed a statistically significant result in favour of cadexomer iodine when compared with standard care (not involving compression) in the frequency of complete healing at six weeks (RR 2.29, 95% CI 1.10 to 4.74). The intervention regimen used was intensive, involving daily dressing changes, and so these findings may not be generalisable to most everyday clinical settings. When cadexomer iodine was compared with standard care with all patients receiving compression, the pooled estimate from two trials for frequency of complete healing at 4 to 6 weeks indicated significantly higher healing rates for cadexomer iodine (RR 6.72, 95% CI 1.56 to 28.95). Surrogate healing outcomes such as change in ulcer surface area and daily or weekly healing rate showed favourable results for cadexomer iodine, peroxide‐based preparations and ethacridine lactate in some studies. These surrogate outcomes may not be valid proxies for complete healing of the wound. Most of the trials were small and many had methodological problems such as poor baseline comparability between groups, failure to use (or report) true randomisation, adequate allocation concealment, blinded outcome assessment and analysis by intention‐to‐treat. Authors' conclusions At present, there is no evidence to support the routine use of systemic antibiotics to promote healing in venous leg ulcers. However, the lack of reliable evidence means that it is not possible to recommend the discontinuation of any of the agents reviewed. In terms of topical preparations, there is some evidence to support the use of cadexomer iodine. Further good quality research is required before definitive conclusions can be made about the effectiveness of systemic antibiotics and topical preparations such as povidone iodine, peroxide‐based preparations, ethacridine lactate, mupirocin and chlorhexidine in healing venous leg ulceration. In light of the increasing problem of bacterial resistance to antibiotics, current prescribing guidelines recommend that antibacterial preparations should only be used in cases of clinical infection and not for bacterial colonisation.
Is treatment with topical or systemic antimicrobial agents associated with better venous leg ulcer healing compared with usual care (dressings and bandages without antimicrobials) or an alternative topical or systemic antimicrobial agent?Available evidence, from underpowered pooled data, neither supports nor refutes an association of systemic antibiotic therapy with improved venous leg ulcer healing. Among topical antimicrobials, cadexomer iodine may be associated with better healing compared with usual care.
This is a protocol for a Cochrane Review (Overview). The objectives are as follows: To summarise all randomised controlled trials (RCTs) regarding the effectiveness of dressings to heal foot ulcers in people with diabetes mellitus (DM).
This chapter reports the findings of a systematic review undertaken to summarize the available evidence on wound dressings for diabetic foot ulcers. The methods included selection of studies, critical appraisal of the studies, collection of the original data and analysis of the results. Eleven studies met the inclusion criteria, two of which were unpublished; nine evaluated wound dressings and two evaluated debriding agents. The outcomes are discussed. The Cochrane Collaboration is committed to maintaining and disseminating systematic reviews: the Wounds Group is keen to hear about ongoing and unpublished trials for inclusion in their review.
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