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The challenge of multicenter studies in diabetic patients with foot infections

Eneroth, Magnus LU ; Larsson, Jan; Apelqvist, Jan LU ; Reike, Heinrich; Salomon, Markus; Gough, Andrew; Foster, Ali and Edmonds, Michael E. (2004) In The Foot 14(4). p.198-203
Abstract

Background: A complexity of factors determines outcome of foot ulcer infections in diabetic subjects. Variations in patient characteristics, treatment strategies and differences in health care systems may influence outcome. Objective: To evaluate the homogeneity in patients with diabetic foot ulcer infections of sufficient severity to warrant antibiotic treatment in three different European foot care centres. Method: A prospective, observational data collection study with agreed on definitions and the same inclusion and exclusion criteria according to a standardised protocol. Patient and wound characteristics, laboratory tests and physical measurements, antibiotic and surgical treatment during 28 days were recorded in 93 patients.... (More)

Background: A complexity of factors determines outcome of foot ulcer infections in diabetic subjects. Variations in patient characteristics, treatment strategies and differences in health care systems may influence outcome. Objective: To evaluate the homogeneity in patients with diabetic foot ulcer infections of sufficient severity to warrant antibiotic treatment in three different European foot care centres. Method: A prospective, observational data collection study with agreed on definitions and the same inclusion and exclusion criteria according to a standardised protocol. Patient and wound characteristics, laboratory tests and physical measurements, antibiotic and surgical treatment during 28 days were recorded in 93 patients. Results: We found significant differences in patient and wound characteristics, in rate and duration of hospitalisation, in antibiotic and surgical treatment, in rate of resolution of infection and in wound healing between centres. Conclusions: Despite using agreed on definitions and the same inclusion and exclusion criteria according to a standardized protocol the heterogeneity between centres of included patients, wound characteristics, management and outcome were surprising. In future multicenter studies, evaluating the effects of a specific treatment of infected foot ulcers in diabetic patients, clear definitions, algorithm for decision making, treatment strategy protocols and knowledge about variations in treatment strategies and healthcare/reimbursement systems in participating centres are needed.

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author
publishing date
type
Contribution to journal
publication status
published
keywords
Definitions, Diabetes mellitus, Foot ulcer, Infection, Multicenter
in
The Foot
volume
14
issue
4
pages
6 pages
publisher
Elsevier
external identifiers
  • scopus:8344240383
ISSN
0958-2592
DOI
10.1016/j.foot.2004.05.001
language
English
LU publication?
no
id
0188d29e-ddcb-44b7-8228-6e10e189b05a
date added to LUP
2017-03-29 08:36:27
date last changed
2017-12-01 15:45:28
@article{0188d29e-ddcb-44b7-8228-6e10e189b05a,
  abstract     = {<p>Background: A complexity of factors determines outcome of foot ulcer infections in diabetic subjects. Variations in patient characteristics, treatment strategies and differences in health care systems may influence outcome. Objective: To evaluate the homogeneity in patients with diabetic foot ulcer infections of sufficient severity to warrant antibiotic treatment in three different European foot care centres. Method: A prospective, observational data collection study with agreed on definitions and the same inclusion and exclusion criteria according to a standardised protocol. Patient and wound characteristics, laboratory tests and physical measurements, antibiotic and surgical treatment during 28 days were recorded in 93 patients. Results: We found significant differences in patient and wound characteristics, in rate and duration of hospitalisation, in antibiotic and surgical treatment, in rate of resolution of infection and in wound healing between centres. Conclusions: Despite using agreed on definitions and the same inclusion and exclusion criteria according to a standardized protocol the heterogeneity between centres of included patients, wound characteristics, management and outcome were surprising. In future multicenter studies, evaluating the effects of a specific treatment of infected foot ulcers in diabetic patients, clear definitions, algorithm for decision making, treatment strategy protocols and knowledge about variations in treatment strategies and healthcare/reimbursement systems in participating centres are needed.</p>},
  author       = {Eneroth, Magnus and Larsson, Jan and Apelqvist, Jan and Reike, Heinrich and Salomon, Markus and Gough, Andrew and Foster, Ali and Edmonds, Michael E.},
  issn         = {0958-2592},
  keyword      = {Definitions,Diabetes mellitus,Foot ulcer,Infection,Multicenter},
  language     = {eng},
  number       = {4},
  pages        = {198--203},
  publisher    = {Elsevier},
  series       = {The Foot},
  title        = {The challenge of multicenter studies in diabetic patients with foot infections},
  url          = {http://dx.doi.org/10.1016/j.foot.2004.05.001},
  volume       = {14},
  year         = {2004},
}