Diabetic foot ulcer development risk classifications' validation: A multicentre prospective cohort study.
OBJECTIVE
To prospectively validate the existing classifications to stratify subjects with diabetes mellitus (DM) by their risk of diabetic foot ulcer (DFU), in high and low risk settings.


METHODS
A prospective multicentre cohort study was conducted, including 446 subjects with DM without active DFU followed in the hospital or primary care setting. Demographic, clinical characterization variables, and those included in the classifications were collected at baseline. Subjects were followed for 1year, until DFU or death.


RESULTS
In our sample, with a mean age of 65years, 52% were male; 32 developed a DFU, 7 required an amputation and 18 died. Differences were found between participants' characteristics and classifications' accuracy according to the setting. The great majority of the variables were associated with higher DFU risk. Globally, classifications were highly and equally valid, positive predictive values (PV) were inferior to 40%, negative PV superior to 90% and area under the receiver operating characteristic curve superior to 0.75.


CONCLUSIONS
All the existing classifications are valid to be applied in high risk clinical context and have a very high capacity to categorize as low risk those subjects that will not develop a DFU. Further research is needed in the primary care setting.
MEDCIDES/CINTESIS - Departamento de Medicina da Comunidade Informação e Decisão em Saúde, Oporto University Faculty of Medicine, Oporto U753-FCT, Portugal. Electronic address: mat.monteirosoares@gmail.com.
M
M
Monteiro-Soares
Unidade de Saúde Familiar Aquae Flaviae, Chaves, Portugal.
R
R
Ribas
Unidade de Saúde Familiar Aquae Flaviae, Chaves, Portugal.
C
C
Pereira da Silva
Unidade de Saúde Familiar Aquae Flaviae, Chaves, Portugal.
T
T
Bral
Unidade de Saúde Familiar Aquae Flaviae, Chaves, Portugal.
A
A
Mota
Unidade de Saúde Familiar Aquae Flaviae, Chaves, Portugal.
S
S
Pinheiro Torres
Unidade de Saúde Familiar Aquae Flaviae, Chaves, Portugal.
A
A
Morgado
Unidade de Saúde Familiar Aquae Flaviae, Chaves, Portugal.
R
R
Couceiro
Unidade de Saúde Familiar Aquae Flaviae, Chaves, Portugal.
R
R
Ribeiro
Unidade de Saúde Familiar Santo André de Canidelo, Vila Nova de Gaia, Portugal.
V
V
Dias
Unidade de Saúde Familiar Santo André de Canidelo, Vila Nova de Gaia, Portugal.
M
M
Moreira
Unidade de Saúde Familiar Santo André de Canidelo, Vila Nova de Gaia, Portugal.
P
P
Mourão
Diabetic Foot Clinic, Endocrinology, Diabetes and Metabolism Department, Centro Hospitalar de Vila Nova de Gaia/Espinho EPE, Vila Nova de Gaia, Portugal.
M J
MJ
Oliveira
Diabetic Foot Clinic, Internal Medicine Department, Centro Hospitalar de Vila Nova de Gaia/Espinho EPE, Vila Nova de Gaia, Portugal.
M
M
Madureira
Diabetic Foot Clinic, Internal Medicine Department, Centro Hospitalar de Vila Nova de Gaia/Espinho EPE, Vila Nova de Gaia, Portugal.
V
V
Paixão-Dias
MEDCIDES/CINTESIS - Departamento de Medicina da Comunidade Informação e Decisão em Saúde, Oporto University Faculty of Medicine, Oporto U753-FCT, Portugal.
M
M
Dinis-Ribeiro
D000368:Aged; D015331:Cohort Studies; D017719:Diabetic Foot / Q000145:classification* / Q000503:physiopathology; D005260:Female; D006801:Humans; D008297:Male; D011446:Prospective Studies; D012307:Risk Factors
Classifications; Diabetic foot; Foot ulcer; Risk